Radius Snare
FDA 510(k) K070502 · Radius Medical Technologies, Inc.
510(k) numberK070502
Submission
- Device name
- Radius Snare
- Applicant
- Radius Medical Technologies, Inc.
Acton, MA, US - Received
- February 21, 2007
- Decision date
- October 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K071457 | Modification to Radius SnareMMX · Special | 09/25/2007SE |
| K032899 | Radius Cougar WireDQX · Special | 10/17/2003SE |
| K032129 | Radius 018 Cougar WireDQX · Special | 07/17/2003SE |
| K022201 | Radius Micro SnareMMX · Traditional | 02/03/2003SE |
| K021441 | Radius SnareMMX · Traditional | 06/14/2002SE |
| K011759 | Radius Next Generation GuidewireOCY · Traditional | 08/23/2001SE |
| K011287 | Radius Cougar WireDQX · Special | 05/25/2001SE |
| K970466 | Radius Ptca GuidewireLIT · Traditional | 05/20/1997SE |
Questions and answers
When was Radius Snare cleared by the FDA?
Radius Snare (K070502) received a 510(k) decision of Substantially Equivalent on October 4, 2007, 225 days after the submission was received.
What is the product code of K070502?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.