Medtronic Vascular: FDA filings under this applicant name

FDA lists 480 510(k) clearances under the applicant name “Medtronic Vascular” (first 1977, latest 2023), plus 20 PMA decisions, across 95 product codes in 12 review panels. Median 510(k) review time under this name: 74 days. Since 2017 the median was 45 days, against 122 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Medtronic, based on public ownership records.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Medtronic Vascular took a median 45 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 122 days.

Top product codes

Plus 85 more product codes.

Review panels

• Cardiovascular (364)
• Neurology (88)
• General and Plastic Surgery (10)
• Physical Medicine (7)
• Radiology (7)
• General Hospital (6)
• Anesthesiology (5)
• Hematology (5)
• Gastroenterology and Urology (3)
• Clinical Chemistry (1)
• Dental (1)
• Orthopedic (1)

Most recent Medtronic Vascular 510(k) clearances

470 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

234 product recalls in 26 recall events; 6 initiated in the last five years. Most recent: 2022-03-23.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Medtronic Vascular is the lead sponsor of 55 device studies on ClinicalTrials.gov (10 active or recruiting). Most recent:

• NCT07081243: Symplicity China Study (Recruiting, started 2025-11-11)
• NCT07174622: Longitudinal Real-world Clinical Outcomes Study on Symplicity Renal Denervation (Recruiting, started 2025-10-28)
• NCT07115953: Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension (Recruiting, started 2025-09-22)
• NCT07013929: Spyral InSight Study (Recruiting, started 2025-06-09)
• NCT06907147: SPYRAL GEMINI Pilot Study (Recruiting, started 2025-05-01)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Medtronic Vascular (a text match, not an official crosswalk):

• C1767 — Generator, neurostimulator (implantable), non-rechargeable (via DXY)
• C9600 — Percutaneous transcatheter placement of drug eluting intracoronary stent(s), with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
• C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via NIQ)
• C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Medtronic Sofamor Danek (253 510(k)s)
• Medtronic, Inc. (247 510(k)s)
• Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
• Medtronic Minimed (57 510(k)s)
• Medtronic Xomed, Inc. (47 510(k)s)
• Medtronic Navigation, Inc. (44 510(k)s)
• Medtronic Perfusion Systems (29 510(k)s)
• Medtronic Neurosurgery (27 510(k)s)
• Medtronic Blood Systems, Inc. (15 510(k)s)
• Medtronic PS Medical (14 510(k)s)
• Medtronic Ave, Inc. (13 510(k)s)
• Medtronic Bio-Medicus, Inc. (13 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Medtronic Vascular?

FDA lists 480 510(k) clearances under the applicant name “Medtronic Vascular” (first 1977, latest 2023), plus 20 PMA decisions, across 95 product codes in 12 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Medtronic Vascular?

The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Vascular is 74 days. Since 2017: 45 days, versus 122 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Medtronic Vascular?

The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 69); DXY (Implantable Pacemaker Pulse-Generator, 59); GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief), 56).

Next steps

• See all 480 Medtronic Vascular clearances with predicates and recalls
• Run predicate analysis for product code DTB, Medtronic Vascular's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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