The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Jostra Pediatric Arterial Prefusion Cannulae.
| Device ID | K072172 |
| 510k Number | K072172 |
| Device Name: | JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Katrin Schwenglenks |
| Correspondent | Katrin Schwenglenks MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2007-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691181684 | K072172 | 000 |
| 04037691051215 | K072172 | 000 |
| 04037691090290 | K072172 | 000 |
| 04037691090269 | K072172 | 000 |
| 04037691404202 | K072172 | 000 |
| 04037691391762 | K072172 | 000 |
| 04037691106724 | K072172 | 000 |
| 04037691181882 | K072172 | 000 |
| 04037691097381 | K072172 | 000 |
| 04037691169187 | K072172 | 000 |
| 04037691106762 | K072172 | 000 |
| 04037691094489 | K072172 | 000 |
| 04037691189055 | K072172 | 000 |