Company ยท US
Cook Vascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2014. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 4 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 3 |
| DYB | Introducer, Catheter | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | 2 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 2014 | K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Cook Vascular, Inc. | DRE |
| Jul 1, 2014 | K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET Cook Vascular, Inc. | DRE |
| Mar 16, 2011 | K110347 | DOPPLER MONITOR Cook Vascular, Inc. | DPW |
| Apr 2, 2009 | K083482 | COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET Cook Vascular, Inc. | FPA |
| Sep 30, 2008 | K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT Cook Vascular, Inc. | LJT |
| May 10, 2006 | K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 Cook Vascular, Inc. | DRE |
| Oct 15, 2003 | K032223 | COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH Cook Vascular, Inc. | GEI |
| May 27, 2003 | K023937 | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM Cook Vascular, Inc. | DYB |
| Sep 6, 2002 | K022649 | COOK-SWARTZ DOPPLER FLOW PROBE Cook Vascular, Inc. | ITX |
| Apr 25, 2002 | K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE Cook Vascular, Inc. | DYB |
| Dec 18, 2001 | K002958 | SHAPEABLE DOPPLER FLOW PROBE Cook Vascular, Inc. | ITX |
| Jun 14, 2001 | K010055 | COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH Cook Vascular, Inc. | DRE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2017 | Cook Vascular Inc. Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S,
Product usage: The devices are intended for use in patient therapy requiring long-ter Terminated |
LJT | K081425 |
| Sep 18, 2008 | Cook Vascular Inc. Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | K983596 |
| Sep 18, 2008 | Cook Vascular Inc. Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | K983596 |
| Sep 17, 2008 | Cook Vascular Inc. Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter Terminated |
LJT | K924748 |
| Sep 17, 2008 | Cook Vascular Inc. Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter Terminated |
LJT | K924748 |
| Sep 16, 2008 | Cook Vascular Inc. Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | K983596 |