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Nmi Ic

by Navilyst Medical, Inc.

510(k) K101326

Nmi Ic is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K101326 on 2 Sep 2010, 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 · Abbreviated NumberK101326 Date2 Sep 2010ClearedStatusActive

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

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

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