510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PTNClass II

Reservoir, Blood, Cardiopulmonary Bypass, Exempt

21 CFR 870.4400 / Cardiovascular
FDA source (opens on fda.gov)

PTN is the FDA product code for Reservoir, Blood, Cardiopulmonary Bypass, Exempt, a class II device type, regulated under 21 CFR 870.4400. FDA's definition for this code reads: "This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PTN
Device name
Reservoir, Blood, Cardiopulmonary Bypass, Exempt
FDA definition
This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code