510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254006Substantially Equivalent

Drivewire 35 Guidewire

Rapid Medical Inc., Yokneam, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254006 is the FDA 510(k) clearance record for Drivewire 35 Guidewire, a class II device, cleared for Rapid Medical Ltd. on under FDA product code MOF (Guide, Wire, Catheter, Neurovasculature). FDA records list 10 510(k) clearances for Rapid Medical Ltd., from to . As of , FDA records show no recalls naming K254006.

Clearance record

Decision date
Received
(214 days to decision)
Product code
MOF Guide, Wire, Catheter, Neurovasculature
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Rapid Medical Ltd. Carmel Bldg., Pob 337, Yokneam, IL
510(k) summary
Summary PDF
Third party review
No

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