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V-Cath 360-78

by Neo Medical Inc.

V-Cath 360-78 is a Class II device made by Neo Medical Inc., cleared under FDA 510(k) K983916 on 23 Nov 1998 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B339360780), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K983916

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB339360780 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK983916 Date23 Nov 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K983916 decided 23 Nov 1998 Active
  • FDA GUDID UDI-DI B339360780 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K983916
  2. Listed FDA GUDID B339360780

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
V-Cath
Generic name
Peripheral intravenous catheterization kit, non-sensing
Model / Ref / Catalog
360-78
Primary DI / UDI-DI
B339360780
510(k) Number
FDA product code
FOZ
GMDN term
Peripheral intravenous catheterization kit, non-sensing
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 20.0 Centimeter
Catheter Gauge — 3.0 French

Related devices

Category: Peripheral intravenous catheterization kit, non-sensing

Cleared under the same submission (K983916)

and 8 more cleared under K983916

Similar devices

Other devices filed under FDA product code FOZ (Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days).

Other devices from Neo Medical Inc.

See all devices from Neo Medical Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)