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Nmi Hpicc III

by Navilyst Medical, Inc.

510(k) K122882

Nmi Hpicc III is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K122882 on 18 Oct 2012, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK122882 Date18 Oct 2012ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LJS
Device class
Class II
Regulation
21 CFR Part 880.5970
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).

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