QUADROX-iD
QUADROX-iD Adult Diffusion Membrane Oxygenator, without Filter, NON-COATED, with a screw connector.
1manufacturer
1catalogue number
13510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Maquet Cardiopulmonary GmbH, Germany |
|---|---|
| FDA product code | DTZ |
| Device type | Oxygenator, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4350 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K150267 |
| Record published | 2017-02-16 |
| Record revised | 2024-09-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 4 |
| Sizes | Total volume 215 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| QUADROX-iD Adult, SOFTLINE Coating, without Filter | Total Volume 215 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oxygenator, Cardiopulmonary Bypass | Medtronic, Inc. | 1,281 |
| Intersept™ | Medtronic, Inc. | 103 |
| Inspire | Sorin Group Italia SRL | 14 |
| Capiox®fx | Terumo Corp. | 14 |
| Capiox®rx | Terumo Corp. | 13 |
| Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U | Spectrum Medical Ltd | 11 |
| Lilliput | Sorin Group Italia SRL | 11 |
| Abiomed Breethe OXY-1 System | Breethe, Inc. | 11 |
| Kids | Sorin Group Italia SRL | 8 |
| Affinity NT™ | Medtronic, Inc. | 8 |
| Affinity Fusion™ | Medtronic, Inc. | 7 |
| QUADROX-i | Maquet Cardiopulmonary GmbH | 7 |
Showing 12 of 69. All products under Oxygenator, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150267 | 2015-05-07 |
| K132829 | 2013-10-08 |
| K112360 | 2011-09-15 |
| K103191 | 2011-03-08 |
| K102464 | 2011-03-04 |
| K101153 | 2010-12-08 |
| K100278 | 2010-04-30 |
| K093522 | 2009-12-07 |
| K090689 | 2009-10-29 |
| K090511 | 2009-06-12 |
| K082117 | 2009-02-18 |
| K071774 | 2008-01-23 |
| K061628 | 2006-08-22 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Maquet Medical Systems, Usa | UDI-DI | 2023-05-18 | Class II | Pending | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory’s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barri | 8,670 (US) | |
| Maquet Medical Systems, Usa | 510(k) number | 2023-05-18 | Class II | Pending | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory’s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barri | 1,784 (US) | |
| Maquet Cardiovascular Us Sales, Llc | 510(k) number | 2016-02-23 | Class II | Unknown/Undetermined by firm | Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products. | 72,000 units in total | 2019-09-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA.
Records are records: nothing here is an offer of sale.