FDA Registration
Active
🇺🇸 United States
COOK VANDERGRIFT INC.
Reg #: 2522007
·
FEI: 2522007
·
Expires 2026
Products
10
Proprietary Names
32
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- COOK VANDERGRIFT INC.
- Registration Number
- 2522007
- FEI Number
- 2522007
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1186 Montgomery Lane
- City
- Vandergrift
- State
- PA
- ZIP
- 15690
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170298
Owner / Operator
- Firm Name
- COOK VANDERGRIFT INC.
- Operator Number
- 2522007
- Address
- 1186 MONTGOMERY LANE, --
- City
- Vandergrift
- State
- PA
- Postal Code
- 15690
- Country
- US
- Correspondent
- Kiley R Laing
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2017-12-11 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2014-12-18 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2011-11-16 |
| Microtools, Assisted Reproduction (Pipettes) | MQH | Class 2 | Obstetrics/Gynecology | No | 2017-01-31 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2008-09-04 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-07-18 |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | Class 2 | Obstetrics/Gynecology | No | 2025-05-15 |
| Transducer, Ultrasonic | JOP | Class 2 | Cardiovascular | No | 2007-12-14 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2018-03-21 |
| Catheter, Embolectomy | DXE | Class 2 | Cardiovascular | No | 2007-12-14 |
Proprietary Names
Stylet Wires
Liberator Beacon Tip Locking Stylet
SteadySheath(R) Evolution(R) Tissue Stabilization Sheath
Evolution(R) Shortie Mechanical Dilator Sheath Set
SteadySheath(R) Evolution(R) Shortie Tissue Stabilization Sheath
Evolution(R) Mechanical Dilator Sheath Set
Byrd Telescoping Stainless Steel Sheath Set
Testicular Sperm Extraction Pipette
Embryo Biopsy Pipette
Polar Body Biopsy Pipette
Flexipet(R) Denuding Pipette
Flexipet(R) Manipulation Pipette
Tunneler
Byrd Dilator Sheath Set - Extra Long Polypropylene
Dilator Sheath Sets
Byrd Dilator Sheath Set - Polypropylene
Evolution(R) Shortie Controlled-Rotation Dilator Sheath Set
Evolution(R) Controlled-Rotation Dilator Sheath Set
Cook-Swartz Doppler Flow Probe
Curved 16 Fr Introducer Set - Femoral
Curved Inner Femoral Sheath
Cook-Swartz Doppler Flow Probe Extension Cable
Doppler Blood Flow Monitor Channel/Cable Verifier
Sof-Grip Hemostat
Coil Expander
Bulldog Lead Extender
One-Tie Compression Coil
Pin Vise Polymer
Needles Eye Snare Retrieval Set
Needles Eye Snare
Needles Eye Snare and Workstation
Needle's Eye Snare Retrieval Set - 54cm
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device