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

Angiography/Angioplasty Kit

21 CFR 870.1650 / Cardiovascular
FDA source (opens on fda.gov)

OEQ is the FDA product code for Angiography/Angioplasty Kit, a class II device type, regulated under 21 CFR 870.1650. 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 89 recalls.

Classification record

Product code
OEQ
Device name
Angiography/Angioplasty 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 870.1650
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
89

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order