Cook Vandergrift, Inc.
Vandergrift, PA, US
COOK VANDERGRIFT INC. appears in FDA device records in Vandergrift, PA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Cook Vandergrift, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Cook Vascular, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Cook Vandergrift, Inc. between 2001 and 2014. The busiest year on record is 2001, with 2. The most recent is 2014, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 2 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2014 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | DRE | Substantially Equivalent | |
| K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE | Substantially Equivalent | |
| K110347 | DOPPLER MONITOR | DPW | Substantially Equivalent | |
| K083482 | COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET | FPA | Substantially Equivalent | |
| K081425 | COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT | LJT | Substantially Equivalent | |
| K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 | DRE | Substantially Equivalent | |
| K032223 | COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH | GEI | Substantially Equivalent | |
| K023937 | COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM | DYB | Substantially Equivalent | |
| K022649 | COOK-SWARTZ DOPPLER FLOW PROBE | ITX | Substantially Equivalent | |
| K010128 | COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE | DYB | Substantially Equivalent | |
| K002958 | SHAPEABLE DOPPLER FLOW PROBE | ITX | Substantially Equivalent | |
| K010055 | COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH | DRE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2522007 | 2522007 | COOK VANDERGRIFT INC. | 1186 Montgomery Lane, Vandergrift, PA 15690 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DXECatheter, Embolectomy
- GCCDilator, Catheter
- DREDilator, Vessel, For Percutaneous Catheterization
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DPWFlowmeter, Blood, Cardiovascular
- MDMInstrument, Manual, Surgical, General Use
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- MQHMicrotools, Assisted Reproduction (Pipettes)
- PUCMicrotools, Assisted Reproduction (Pipettes), Exempt
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular
- FPASet, Administration, Intravascular
- DRBStylet, Catheter
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2513-2023 | Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001 | Sterility of device may be compromised due to breach of the chevron seal of the packaging | Class II | Open, Classified | |
| Z-1223-2018 | 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-term vascular access for infusion therapy and/or blood sampling. | Non-coring needle provided with the Cook Vital-Port Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall. | Class II | Terminated | |
| Z-2191-2008 | Vital Port Vascular Access System Polysulfone Petite with detached 1.0mm catheter | mislabeled - wrong size catheter was packaged in the box | Terminated | ||
| Z-2190-2008 | Vital Port Vascular Access System Polysulfone Petite with detached 0.9mm catheter | Mislabeled - wrong size catheter was packaged in the box | Terminated | ||
| Z-2177-2008 | Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes. | mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | Terminated | ||
| Z-2176-2008 | 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. | mislabeled - 300 micron flexipets labeled as 130 micron and vice versa | Terminated | ||
| Z-2178-2008 | 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. | mislabeled - 300 micron flexipets were labeled as 80 microns | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain