V-CATH
by Hdc Corp.
510(k) K964966
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964966 | Date5 Mar 1997 | StatusActive |
Official records
- FDA 510(k) database K964966
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FOZ
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
V-CATH is a percutaneous introducer kit. It is a device used for vascular access procedures.
The device is manufactured by Hdc Corp. and has received FDA 510(k) clearance under K964966. It is supplied as a kit for clinical use in general hospital settings.
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Other devices filed under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days).
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