The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Cobe Smarxt Tubing And Connectors.
| Device ID | K981613 |
| 510k Number | K981613 |
| Device Name: | COBE SMARXT TUBING AND CONNECTORS |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-06 |
| Decision Date | 1998-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622129381 | K981613 | 000 |
| 10803622124966 | K981613 | 000 |
| 10803622124973 | K981613 | 000 |
| 10803622124980 | K981613 | 000 |
| 10803622129282 | K981613 | 000 |
| 10803622129299 | K981613 | 000 |
| 10803622129305 | K981613 | 000 |
| 10803622129312 | K981613 | 000 |
| 10803622129329 | K981613 | 000 |
| 10803622129336 | K981613 | 000 |
| 10803622129343 | K981613 | 000 |
| 10803622129350 | K981613 | 000 |
| 10803622129367 | K981613 | 000 |
| 10803622129374 | K981613 | 000 |
| 10803622124959 | K981613 | 000 |