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FDA 510(k), K040298, ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
FDA 510(k), K040298, ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
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510(K) Number: K040298
Device Name: ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
Manufacturer: ACIST MEDICAL SYSTEMS, INC.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 02/09/2004
Decision Date: 03/15/2004
Regulation Medical Specialty: Cardiovascular
Device Name: ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISPOSABLE KITS
Manufacturer: ACIST MEDICAL SYSTEMS, INC.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 02/09/2004
Decision Date: 03/15/2004
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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