OFCClass II

Catheter Introducer Kit

21 CFR 870.1340 / Cardiovascular

OFC is the FDA product code for Catheter Introducer Kit, a class II device type, regulated under 21 CFR 870.1340. FDA's definition for this code 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 guidance above, is under enforcement discretion, and does not require a premarket...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2010-03-26, and 4 recalls.

Classification record

Product code: OFC
Device name: Catheter Introducer Kit
FDA 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.
Regulation: 21 CFR 870.1340
Device class: Class II
Review panel: Cardiovascular
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 4

Clearances, product code OFC

By decision year

1 clearance under product code OFC with a decision year between 2010 and 2010, 2010 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OFC by decision year
Year	Clearances
2010	1

Applicants with the most clearances

Product code OFC

Applicants holding the most 510(k) clearances under product code OFC
Applicant	Clearances
Spectranetics Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order