510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010954Substantially Equivalent

Concentric Balloon Guide Catheter, Model 90031

Concentric Medical, Inc., Moutian View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010954 is the FDA 510(k) clearance record for CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031, a class II device, cleared for Concentric Medical, Inc. on under FDA product code DQY (Catheter, Percutaneous). FDA records list 46 510(k) clearances for Concentric Medical, Inc., from to . As of , FDA records show one recall naming K010954.

Clearance record

Decision date
Received
(193 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Concentric Medical, Inc. 2585 Leghorn St., Moutian View CA
510(k) summary
Summary
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260