Sarns™ Cardioplegia Set
2 catalogue numbers from 14915, listed by Terumo Cardiovascular Systems Corporation, United States, under Accessory Equipment, Cardiopulmonary Bypass. 1 manufacturer in China is registered for 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 | Terumo Cardiovascular Systems Corporation, United States |
|---|---|
| FDA product code | KRI |
| Device type | Accessory Equipment, Cardiopulmonary Bypass |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K810079 |
| Record published | 2015-10-02 |
| Record revised | 2021-10-19 (version 4) |
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 |
| Packaging | 4 piece case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14915 | In distribution | |
| 16200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bracket | LivaNova USA, Inc. | 16 |
| Accessory Equipment, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 15 |
| VivaCart | CardioQuip | 14 |
| Capiox | Terumo Corp. | 12 |
| CentriMag™ | Thoratec Corp. | 11 |
| LifeSPARC | Cardiacassist, Inc. | 9 |
| Quantum | Spectrum Medical Ltd | 8 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 8 |
| Terumo® Advanced Perfusion System 1 | Terumo Cardiovascular Systems Corporation | 6 |
| Novatemp | Novamed-USA | 5 |
| Inspire | Sorin Group Italia SRL | 5 |
| Holder | Eurosets SRL | 4 |
Showing 12 of 108. All products under Accessory Equipment, Cardiopulmonary Bypass
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Terumo Cardiovascular Systems Corporation | 510(k) number | 2011-03-01 | Class II | Device Design | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line | 165 units | 2014-11-06 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-08-12 | Not classified | Incorrect or no expiration date | Level Sensor II mounting pads may not stick to the venous reservoir and may detach either at case setup or during a case. | 1,531,440 devices | 2012-06-20 |
| 2009-10-02 | Class II | Labeling design | Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. The devices were manufactured and configured with two 3/8 inch and one inch connector supports instead of one 3/8 inch and two inch conne | 33 units | 2013-01-29 |
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.