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FDA 510(k), K150445, ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
FDA 510(k), K150445, ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
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510(K) Number: K150445
Device Name: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
Manufacturer: ASAHI INTECC CO., LTD.
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 02/20/2015
Decision Date: 06/30/2015
Regulation Medical Specialty: Cardiovascular
Device Name: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
Manufacturer: ASAHI INTECC CO., LTD.
Device Classification Name: wire, guide, catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 02/20/2015
Decision Date: 06/30/2015
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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