INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
FDA 510(k) clearance K131446 · decided 2013-10-28
Clearance details
- K-number
- K131446
- Device name
- INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
- Applicant
- Integra LifeSciences Corporation
- Decision
- Substantially Equivalent
- Date received
- 2013-05-20
- Decision date
- 2013-10-28
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- DQR
- Device class
- 2
- Regulation number
- 870.1300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II (K073559) | Edwards Lifesciences Research Medical | 2008-01-31 |
| ANGIODYNAMICS, INC., MICRO ACCESS KITS (K051655) | AngioDynamics, Inc. | 2005-09-12 |
| CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 (K030398) | Cardiacassist, Inc. | 2003-05-23 |
| RMI INTERNAL MAMMARY ARTERY CANNULA (K960098) | Research Medical, Inc. | 1996-03-26 |
| DATASCOPE ARTERIAL CANNULA W/ACCESS PORT (K902674) | Datascope Corp. | 1991-01-16 |
| MODIFIED SHILEY FEMORAL VENOUS CANNULA (K894784) | Shiley, Inc. | 1990-03-28 |
| RMI ARTERIAL PERFUSION CANNULA (K894243) | Research Medical, Inc. | 1989-09-19 |
| HARBORIN CENTRAL VENOUS CATHETER (K884628) | Harbor Medical Devices, Inc. | 1989-05-15 |
| DAIG COLLAPSIBLE STERILE SLEEVE (K884478) | Daig Corp. | 1989-02-22 |
| TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER (K884375) | Argon Medical Corp. | 1989-01-11 |
| ASK-300 (K882977) | Medical Repackers Co. | 1989-01-05 |
| HARBOR CENTRAL VENOUS CATHETER (K881884) | Harbor Medical Devices, Inc. | 1988-07-28 |
Recalls involving this device
No recalls on record reference this clearance.