CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
FDA 510(k) clearance K113667 · decided 2012-01-12
Clearance details
- K-number
- K113667
- Device name
- CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-12-13
- Decision date
- 2012-01-12
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Draper, UT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Edwards Lifesciences
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Attachable Cath Lab Hemostasis Valve (K152528) | Galt Medical Corp. | 2015-12-02 |
| Passage Hemostasis Valve (K143429) | Merit Medical Systems, Inc. | 2014-12-22 |
| ROTATING ADAPTERS (K140475) | Merit Medical Systems, Inc. | 2014-04-16 |
| COLIGN (K131124) | Jilin Coronado Medical , Ltd. | 2013-08-28 |
| AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE (K123448) | Medtronic, Inc. | 2012-12-13 |
| CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (K122811) | Medtronic, Inc. | 2012-10-12 |
| GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (K122301) | Vascular Solutions Zerusa , Ltd. | 2012-09-07 |
| MEDLINE STOPCOCK AND MANIFOLD (K120069) | Medline Industries, Inc. | 2012-04-03 |
| E-PASS (K113148) | Synexmed(Shenzhen)Company Limited | 2012-02-28 |
| TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (K113845) | Medtronic, Inc. | 2012-01-25 |
| DISPOSABLE HEMOSTATIC Y-CONNECTORS (K113132) | Coeur, Inc. | 2012-01-20 |
| GUARDIAN II NC HEMOSTASIS VALVE (K101113) | Zerusa Limited | 2010-05-21 |
Recalls involving this device
No recalls on record reference this clearance.