The following data is part of a premarket notification filed by Haemonetics Corp. with the FDA for Orthopat Advance Perioperative Autotransfusion System.
| Device ID | K122262 |
| 510k Number | K122262 |
| Device Name: | ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM |
| Classification | Apparatus, Autotransfusion |
| Applicant | HAEMONETICS CORP. 4925 Robert J Mathews Pkwy Ste 100 El Dorado Hills, CA 95762 |
| Contact | Erica Diaz |
| Correspondent | Erica Diaz HAEMONETICS CORP. 4925 Robert J Mathews Pkwy Ste 100 El Dorado Hills, CA 95762 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-27 |
| Decision Date | 2012-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30812747017910 | K122262 | 000 |
| 30812747017200 | K122262 | 000 |