The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Modification Of Bard Quantum Cvr, Model H-6770vr.
| Device ID | K990514 |
| 510k Number | K990514 |
| Device Name: | MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | C.R. BARD, INC. 25 COMPUTER DR. Haverhill, MA 01832 |
| Contact | Sandra Perreand |
| Correspondent | Sandra Perreand C.R. BARD, INC. 25 COMPUTER DR. Haverhill, MA 01832 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-18 |
| Decision Date | 1999-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B066H11363 | K990514 | 000 |
| B066H11360 | K990514 | 000 |