Cook Vascular, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Cook Vascular, Inc.” (first 2001, latest 2014), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 108 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 2 | 72 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 4 | 4 |
| DYB | Introducer, Catheter | 2 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 1 | 1 |
Review panels
Most recent Cook Vascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | DRE | 2014-11-12 | 86 |
| K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE | 2014-07-01 | 57 |
| K110347 | DOPPLER MONITOR | DPW | 2011-03-16 | 37 |
| K083482 | COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET | FPA | 2009-04-02 | 129 |
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT | LJT | 2008-09-30 | 132 |
| K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 | DRE | 2006-05-10 | 29 |
| K032223 | COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH | GEI | 2003-10-15 | 86 |
| K023937 | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM | DYB | 2003-05-27 | 182 |
| K022649 | COOK-SWARTZ DOPPLER FLOW PROBE | ITX | 2002-09-06 | 28 |
| K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE | DYB | 2002-04-25 | 464 |
2 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2017-11-28.
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.
- Cook, Inc. (190 510(k)s)
- Cook Incorporated (174 510(k)s)
- Cook Urological, Inc. (104 510(k)s)
- Cook Ob/Gyn (43 510(k)s)
- Cook Pacemaker Corp. (34 510(k)s)
- Cook Ireland, Ltd. (33 510(k)s)
- Cook Biotech, Inc. (31 510(k)s)
- Cook Biotech Incorporated (16 510(k)s)
- Cook Endoscopy (4 510(k)s)
- Cook Biotech Incorprated (4 510(k)s)
- Cook Advanced Technologies (1 510(k)s)
- Cook (Canada), Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cook Vascular, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Cook Vascular, Inc.” (first 2001, latest 2014), across 7 product codes in 4 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 Cook Vascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cook Vascular, Inc. is 108 days.
Which FDA product codes appear under Cook Vascular, Inc.?
The most frequent FDA product codes under this applicant name are DRE (Dilator, Vessel, For Percutaneous Catheterization, 4); DYB (Introducer, Catheter, 2); ITX (Transducer, Ultrasonic, Diagnostic, 2).
Next steps
- See all 12 Cook Vascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRE, Cook Vascular, Inc.'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.