510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093257Substantially Equivalent

Torqmax Sheath Grip Accessory

Spectranetics Corp., Colorado Springs CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093257 is the FDA 510(k) clearance record for TORQMAX SHEATH GRIP ACCESSORY, a class II device, cleared for Spectranetics Corp. on under FDA product code OFC (Catheter Introducer Kit). FDA's definition for product code OFC reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the...". FDA records list 57 510(k) clearances for Spectranetics Corp., from to . As of , FDA records show no recalls naming K093257.

Clearance record

Decision date
Received
(158 days to decision)
Product code
OFC Catheter Introducer Kit
Regulation
21 CFR 870.1340
Device class
Class II
Review panel
Cardiovascular
Applicant
Spectranetics Corp. 9965 Federal Dr., Colorado Springs CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OFC

Trailing 12 months

FDA records hold no clearances under product code OFC in the trailing twelve months.

FDA records show no clearances under product code OFC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OFC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260