Datascope Arterial Cannula W/Access Port
FDA 510(k) K902674 · Datascope Corp.
510(k) numberK902674
Submission
- Device name
- Datascope Arterial Cannula W/Access Port
- Applicant
- Datascope Corp.
Oakland, NJ, US - Received
- June 18, 1990
- Decision date
- January 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQR – Cannula, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1300
- Specialty
- Cardiovascular
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| K051655 | Angiodynamics, Inc., Micro Access KitsDQR · Traditional | AngioDynamics, Inc. | 09/12/2005SE |
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| 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 Datascope Arterial Cannula W/Access Port cleared by the FDA?
Datascope Arterial Cannula W/Access Port (K902674) received a 510(k) decision of Substantially Equivalent on January 16, 1991, 212 days after the submission was received.
What is the product code of K902674?
The FDA product code is DQR – Cannula, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1300.