AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
FDA 510(k) clearance K123448 · decided 2012-12-13
Clearance details
- K-number
- K123448
- Device name
- AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-08
- Decision date
- 2012-12-13
- Days to decision
- 35 days
- Clearance type
- Special
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtronic
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 |
| 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 |
| CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING (K113667) | Edwards Lifesciences, LLC | 2012-01-12 |
| GUARDIAN II NC HEMOSTASIS VALVE (K101113) | Zerusa Limited | 2010-05-21 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455) | Medtronic, Inc. | 2025-12-22 |
| Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527) | Medtronic, Inc. | 2025-12-22 |
| Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574) | Medtronic, Inc. | 2025-12-19 |
| SynchroMed Infusion Systems (P860004/S453) | Medtronic, Inc. | 2025-12-19 |
| Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526) | Medtronic, Inc. | 2025-12-18 |
| Activa Deep Brain Stimulation Therapy System (P960009/S514) | Medtronic, Inc. | 2025-12-17 |
| Aurora EV-ICD System (P220012/S061) | Medtronic, Inc. | 2025-12-15 |
| Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense (P960009/S524) | Medtronic, Inc. | 2025-12-08 |