Integra Jarit Heparin Cannulas, Injectors, and Needles
FDA 510(k) K131446 · Integra LifeSciences Corporation
510(k) numberK131446
Submission
- Device name
- Integra Jarit Heparin Cannulas, Injectors, and Needles
- Applicant
- Integra LifeSciences Corporation
York, PA, US - Received
- May 20, 2013
- Decision date
- October 28, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQR – Cannula, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1300
- Specialty
- Cardiovascular
Other 510(k)s with product code DQR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K073559 | 18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula IIDQR · Special | Edwards Lifesciences Research Medical | 01/31/2008SE |
| K051655 | Angiodynamics, Inc., Micro Access KitsDQR · Traditional | AngioDynamics, Inc. | 09/12/2005SE |
| K030398 | Cardiacassist Transseptal Cannula Set, Model 5132-6221DQR · Traditional | Cardiacassist, Inc. | 05/23/2003SE |
| K960098 | Rmi Internal Mammary Artery CannulaDQR · Traditional | Research Medical, Inc. | 03/26/1996SE |
| K902674 | Datascope Arterial Cannula W/Access PortDQR · Traditional | Datascope Corp. | 01/16/1991SE |
| K894784 | Modified Shiley Femoral Venous CannulaDQR · Traditional | Shiley, Inc. | 03/28/1990SE |
| K894243 | Rmi Arterial Perfusion CannulaDQR · Traditional | Research Medical, Inc. | 09/19/1989SE |
| K884628 | Harborin Central Venous CatheterDQR · Traditional | Harbor Medical Devices, Inc. | 05/15/1989SE |
| K884478 | Daig Collapsible Sterile SleeveDQR · Traditional | Daig Corp. | 02/22/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | Argon Medical Corp. | 01/11/1989SE |
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Questions and answers
When was Integra Jarit Heparin Cannulas, Injectors, and Needles cleared by the FDA?
Integra Jarit Heparin Cannulas, Injectors, and Needles (K131446) received a 510(k) decision of Substantially Equivalent on October 28, 2013, 161 days after the submission was received.
What is the product code of K131446?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.