Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ
FDA 510(k) K122469 · Asahi Intecc Co., Ltd.
510(k) numberK122469
Submission
- Device name
- Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ
- Applicant
- Asahi Intecc Co., Ltd.
Santa Ana, CA, US - Received
- August 13, 2012
- Decision date
- March 8, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K251240 | Branchor X Balloon Guide CatheterQJP · Traditional | 06/20/2025SE |
| K243383 | CHIKAI Nexus 014MOF · Traditional | 04/21/2025SE |
| K243733 | SION blue PLUSDQX · Special | 04/02/2025SE |
| K241962 | CrossloopDQX · Traditional | 03/27/2025SE |
| K242597 | CROSSLEAD 0.018inchDQX · Special | 03/05/2025SE |
| K241702 | CROSSLEAD 0.014inchDQX · Special | 02/06/2025SE |
| K241801 | Tornus ESFGE · Traditional | 12/17/2024SE |
Questions and answers
When was Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ cleared by the FDA?
Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJ (K122469) received a 510(k) decision of Substantially Equivalent on March 8, 2013, 207 days after the submission was received.
What is the product code of K122469?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.