The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i, Quadrox-id, Quadrox-ir Oxygenators.
Device ID | K132829 |
510k Number | K132829 |
Device Name: | QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
Contact | Whitney Torning |
Correspondent | Whitney Torning MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
Product Code | DTZ |
Subsequent Product Code | DTM |
Subsequent Product Code | DTR |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2013-09-09 |
Decision Date | 2013-10-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04037691843353 | K132829 | 000 |
04058863299983 | K132829 | 000 |
04037691870304 | K132829 | 000 |
04037691452982 | K132829 | 000 |
04037691670171 | K132829 | 000 |
04037691725079 | K132829 | 000 |
04037691727868 | K132829 | 000 |
04037691739335 | K132829 | 000 |
04037691741161 | K132829 | 000 |
04037691770987 | K132829 | 000 |
04037691780481 | K132829 | 000 |
04037691782089 | K132829 | 000 |
04037691873060 | K132829 | 000 |