The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Wm. Harvey Overpressure Safety Valve.
| Device ID | K820297 |
| 510k Number | K820297 |
| Device Name: | WM. HARVEY OVERPRESSURE SAFETY VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-04 |
| Decision Date | 1982-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753450238 | K820297 | 000 |
| 50699753450221 | K820297 | 000 |