Cri Cynosar Catheter
FDA 510(k) K900320 · Catheter Research C/O Burditt, Bowles & Radzius
510(k) numberK900320
Submission
- Device name
- Cri Cynosar Catheter
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
Indianapolis, IN, US - Received
- January 23, 1990
- Decision date
- September 14, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
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| K232321 | FlexCath Contour Steerable SheathDRA · Traditional | Medtronic, Inc. | 10/31/2023SE |
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| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/05/2022SE |
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| K202620 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | Medtronic Cryocath, LP | 11/13/2020SE |
| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
More from Freudenberg Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K924227 | Cri Cynosar CatheterDRA · Traditional | 06/29/1993SE |
| K924125 | Cri Electronic Control SystemDXX · Traditional | 05/26/1993SE |
| K914523 | Cri Vessel Occlusin System/Cri Occlusion CoilDSS · Traditional | 01/10/1992SE |
| K904785 | Cri Cynosar CatheterDRA · Traditional | 03/06/1991SE |
| K904787 | Cri Steerable Catheter Control SystemDXX · Traditional | 12/17/1990SE |
| K884337 | Micro-Guide SystemDRA · Traditional | 01/05/1989SE |
| K870700 | Micro-GuideDQO · Traditional | 12/03/1987SE |
Questions and answers
When was Cri Cynosar Catheter cleared by the FDA?
Cri Cynosar Catheter (K900320) received a 510(k) decision of Substantially Equivalent on September 14, 1990, 234 days after the submission was received.
What is the product code of K900320?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.