Micro-Guide System
FDA 510(k) K884337 · Catheter Research C/O Burditt, Bowles & Radzius
510(k) numberK884337
Submission
- Device name
- Micro-Guide System
- Applicant
- Catheter Research C/O Burditt, Bowles & Radzius
Chicago, IL, US - Received
- October 14, 1988
- Decision date
- January 5, 1989
- 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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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 |
| K900320 | Cri Cynosar CatheterDRA · Traditional | 09/14/1990SE |
| K870700 | Micro-GuideDQO · Traditional | 12/03/1987SE |
Questions and answers
When was Micro-Guide System cleared by the FDA?
Micro-Guide System (K884337) received a 510(k) decision of Substantially Equivalent on January 5, 1989, 83 days after the submission was received.
What is the product code of K884337?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.