ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
FDA 510(k) K171933 · Asahi Intecc Co., Ltd.
510(k) numberK171933
Submission
- Device name
- ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
- Applicant
- Asahi Intecc Co., Ltd.
Hagoya-Shi, JP - Received
- June 28, 2017
- Decision date
- February 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K243733 | SION blue PLUSDQX · Special | 04/02/2025SE |
| K241962 | CrossloopDQX · Traditional | 03/27/2025SE |
| K242597 | CROSSLEAD 0.018inchDQX · Special | 03/05/2025SE |
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Questions and answers
When was ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter cleared by the FDA?
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter (K171933) received a 510(k) decision of Substantially Equivalent on February 12, 2018, 229 days after the submission was received.
What is the product code of K171933?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.