The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Conducer Cardioplegia Set Sith Mp4.
| Device ID | K922992 |
| 510k Number | K922992 |
| Device Name: | CONDUCER CARDIOPLEGIA SET SITH MP4 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Contact | Cathy L Simpson |
| Correspondent | Cathy L Simpson 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor, MI 48106 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-22 |
| Decision Date | 1992-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50699753005476 | K922992 | 000 |