COOK CHORIONIC VILLUS SAMPLING SET
FDA premarket approval P900007 · decided 1994-09-30
Approval details
- PMA number
- P900007
- Trade name
- COOK CHORIONIC VILLUS SAMPLING SET
- Generic name
- Catheter, sampling, chorionic villus
- Applicant
- Cook Incorporated
- Date received
- 1990-02-01
- Decision date
- 1994-09-30
- Days to decision
- 1702 days
- Decision code
- APPR
- Product code
- LLX
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
- Location
- Bloomington, IN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Nest VT Vitrification Device (K233177) | Cook Incorporated | 2024-03-08 |
| Gunther Tulip Vena Cava Filter Retrieval Set (K222254) | Cook Incorporated | 2023-05-16 |
| Bakri Essential Postpartum Balloon (K223098) | Cook Incorporated | 2022-10-28 |
| Endovascular Dilator and Sets (K210734) | Cook Incorporated | 2021-04-06 |
| Extra Large Check-Flo Introducer (K203670) | Cook Incorporated | 2021-02-16 |
| Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc (K191498) | Cook Incorporated | 2020-01-29 |
| Lawson Retrograde Nephrostomy Wire Puncture Set (K190903) | Cook Incorporated | 2019-12-16 |
| Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set (K193133) | Cook Incorporated | 2019-12-12 |