Medtronic Cryocath, LP: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Medtronic Cryocath, LP” (first 2010, latest 2020), plus 2 PMA decisions, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 42 days. Since 2017 the median was 64 days, against 64 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 36 |
| 2013 | 0 | — |
| 2014 | 1 | 48 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 73 |
| 2018 | 1 | 10 |
| 2019 | 0 | — |
| 2020 | 1 | 64 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtronic Cryocath, LP took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 64 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRA | Catheter, Steerable | 4 | 4 |
| DYB | Introducer, Catheter | 2 | 2 |
| LPB | Cardiac Ablation Percutaneous Catheter | 1 | 0 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 1 | 0 |
Review panels
- Cardiovascular (8)
Most recent Medtronic Cryocath, LP 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202620 | FlexCath Advance Steerable Sheath and Dilator | DRA | 2020-11-13 | 64 |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | DRA | 2018-11-26 | 10 |
| K163268 | FlexCath Select Steerable Shealth and Dilator | DYB | 2017-02-02 | 73 |
| K142684 | FlexCath Select Steerable Sheath (10 French) | DYB | 2014-11-06 | 48 |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | DRA | 2012-12-27 | 36 |
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10 | DRA | 2010-09-01 | 29 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P100010 | PMA | ARCTIC FRONT CRYOCATHETER SYSTEM | 2010-12-17 |
| P020045 | PMA | 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM | 2003-04-17 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Cryocath, LP.
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.
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 Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (184 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Cryocath, LP?
FDA lists 6 510(k) clearances under the applicant name “Medtronic Cryocath, LP” (first 2010, latest 2020), plus 2 PMA decisions, across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medtronic Cryocath, LP?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Cryocath, LP is 42 days. Since 2017: 64 days, versus 64 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medtronic Cryocath, LP?
The most frequent FDA product codes under this applicant name are DRA (Catheter, Steerable, 4); DYB (Introducer, Catheter, 2); LPB (Cardiac Ablation Percutaneous Catheter, 1).
Next steps
- See all 6 Medtronic Cryocath, LP clearances with predicates and recalls
- Run predicate analysis for product code DRA, Medtronic Cryocath, LP'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.