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

Percutaneous Sheath Introducer Kit

21 CFR 870.1340 / Cardiovascular
FDA source (opens on fda.gov)

OFL is the FDA product code for Percutaneous Sheath 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 , FDA records hold no 510(k) clearances under this code and 5 recalls.

Classification record

Product code
OFL
Device name
Percutaneous Sheath 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
0
Ingested recalls
5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order