510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182337Substantially Equivalent

HYBRID Guidewire

Balt USA, LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182337 is the FDA 510(k) clearance record for HYBRID Guidewire, a class II device, cleared for Balt USA, LLC on under FDA product code MOF (Guide, Wire, Catheter, Neurovasculature). FDA records list 19 510(k) clearances for Balt USA, LLC, from to . As of , FDA records show no recalls naming K182337.

Clearance record

Decision date
Received
(37 days to decision)
Product code
MOF Guide, Wire, Catheter, Neurovasculature
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Balt USA, LLC 29 Parker, Irvine CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MOF

Trailing 12 months
12 clearances under product code MOF in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MOF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20262
March 20262
April 20262
May 20260
June 20260
July 20261
August 20263
September 20261
October 20260