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FDA 510(k), K113819, MONGOOSE ANGIOGRAPHIC CATHETER
FDA 510(k), K113819, MONGOOSE ANGIOGRAPHIC CATHETER
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510(K) Number: K113819
Device Name: MONGOOSE ANGIOGRAPHIC CATHETER
Manufacturer: PEDIACATH INC.
Device Classification Name: catheter, intravascular, diagnostic
Regulation Number: 870.1200
Classification Product Code: DQO
Date Received: 12/27/2011
Decision Date: 07/11/2012
Regulation Medical Specialty: Cardiovascular
Device Name: MONGOOSE ANGIOGRAPHIC CATHETER
Manufacturer: PEDIACATH INC.
Device Classification Name: catheter, intravascular, diagnostic
Regulation Number: 870.1200
Classification Product Code: DQO
Date Received: 12/27/2011
Decision Date: 07/11/2012
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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