The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Haemonetics Cardiovascular Perioperative Autotransfusion System.
| Device ID | K043127 |
| 510k Number | K043127 |
| Device Name: | HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Contact | Gabriel J Muraca |
| Correspondent | Gabriel J Muraca HAEMONETICS CORP. 400 WOOD RD. P.O. BOX 9114 Braintree, MA 02184 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2005-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747017323 | K043127 | 000 |
| 30812747017316 | K043127 | 000 |