Product code OFC— Cardiovascular

TORQMAX SHEATH GRIP ACCESSORY

Classification name: Catheter Introducer Kit
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Total cleared: 1
First cleared: 2010-03-26
Most recent: 2010-03-26

FDA classification definition

“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 guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.”
— U.S. Food and Drug Administration, device classification record for product code OFC under 21 CFR 870.1340, via openFDA

Market context for product code OFC

FDA has cleared 1 device under product code OFC, all in 2010, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OFC

Spectranetics Corp.1 clearance

Recent clearances under product code OFC

K093257 — TORQMAX SHEATH GRIP ACCESSORYSpectranetics Corp.·2010-03-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.