510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121954Substantially Equivalent

Nmi Microcatheter

Boston Scientific Corporation, Marlborough MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121954 is the FDA 510(k) clearance record for NMI MICROCATHETER, a class II device, cleared for Navilyst Medical, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K121954.

Clearance record

Decision date
Received
(14 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
Navilyst Medical, Inc. 26 Forest St., Marlborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQO

Trailing 12 months
3 clearances under product code DQO in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DQO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260