The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for William Harvey H-625 Arterial Filter.
Device ID | K820472 |
510k Number | K820472 |
Device Name: | WILLIAM HARVEY H-625 ARTERIAL FILTER |
Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTM |
CFR Regulation Number | 870.4260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-02-19 |
Decision Date | 1982-03-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B0662010080000 | K820472 | 000 |
B066H79153 | K820472 | 000 |
B066H75563 | K820472 | 000 |
B066H73953 | K820472 | 000 |