The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quadrox-i Adult/small Adult Oxygenators;quadrox-id Adult Oxygenators.
Device ID | K150267 |
510k Number | K150267 |
Device Name: | QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
Contact | Whitney Torning |
Correspondent | Whitney Torning MAQUET Cardiovascular 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-04 |
Decision Date | 2015-05-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04058863019192 | K150267 | 000 |
04037692010594 | K150267 | 000 |
04037692010570 | K150267 | 000 |
04037692009925 | K150267 | 000 |
04037692009932 | K150267 | 000 |
04037692010556 | K150267 | 000 |
04037692010563 | K150267 | 000 |
04037692010532 | K150267 | 000 |
04037692011379 | K150267 | 000 |
04058863017358 | K150267 | 000 |
04058863017389 | K150267 | 000 |
04058863019000 | K150267 | 000 |
04058863019024 | K150267 | 000 |
04058863019062 | K150267 | 000 |
04058863019086 | K150267 | 000 |
04058863019154 | K150267 | 000 |
04058863019178 | K150267 | 000 |
04037692010471 | K150267 | 000 |