ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
FDA 510(k) K150445 · Asahi Intecc Co., Ltd.
510(k) numberK150445
Submission
- Device name
- ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
- Applicant
- Asahi Intecc Co., Ltd.
Hagoya-Shi, JP - Received
- February 20, 2015
- Decision date
- June 30, 2015
- 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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Questions and answers
When was ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) cleared by the FDA?
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) (K150445) received a 510(k) decision of Substantially Equivalent on June 30, 2015, 130 days after the submission was received.
What is the product code of K150445?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.