The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Jostra Hlm Tubing Set.
| Device ID | K053025 |
| 510k Number | K053025 |
| Device Name: | JOSTRA HLM TUBING SET |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG P.O. BOX 2042 Fairfield, IA 52556 |
| Contact | Kathleen Johnson |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-10-27 |
| Decision Date | 2005-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607567212725 | K053025 | 000 |
| 00607567205895 | K053025 | 000 |
| 00607567205390 | K053025 | 000 |
| 00607567205093 | K053025 | 000 |
| 00607567204898 | K053025 | 000 |
| 00607567204324 | K053025 | 000 |
| 00607567203846 | K053025 | 000 |
| 00607567203785 | K053025 | 000 |
| 00607567203488 | K053025 | 000 |
| 00607567203372 | K053025 | 000 |
| 00607567202740 | K053025 | 000 |
| 00607567200173 | K053025 | 000 |
| 00607567200098 | K053025 | 000 |
| 00607567200074 | K053025 | 000 |
| 00607567200067 | K053025 | 000 |
| 00607567200050 | K053025 | 000 |
| 00607567205901 | K053025 | 000 |
| 00607567206328 | K053025 | 000 |
| 00607567211803 | K053025 | 000 |
| 00607567211537 | K053025 | 000 |
| 00607567211308 | K053025 | 000 |
| 00607567211292 | K053025 | 000 |
| 00607567210882 | K053025 | 000 |
| 00607567209060 | K053025 | 000 |
| 00607567208599 | K053025 | 000 |
| 00607567208568 | K053025 | 000 |
| 00607567207769 | K053025 | 000 |
| 00607567207752 | K053025 | 000 |
| 00607567207035 | K053025 | 000 |
| 00607567206571 | K053025 | 000 |
| 00607567206489 | K053025 | 000 |
| 00607567206472 | K053025 | 000 |
| 00607567206380 | K053025 | 000 |
| 00607567200043 | K053025 | 000 |