FDA 510(k), K881088, ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
FDA 510(k), K881088, ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
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510(K) Number: K881088
Device Name: ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
Manufacturer: DIANE RUPPERT
Device Classification Name: Catheter, Angioplasty, Peripheral, Transluminal
Regulation Number: LIT
Classification Product Code: 03/15/1988
Date Received: 05/31/1988
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ADDITION OF A TIP GUARD TO THE ATHEROCATH(TM)
Manufacturer: DIANE RUPPERT
Device Classification Name: Catheter, Angioplasty, Peripheral, Transluminal
Regulation Number: LIT
Classification Product Code: 03/15/1988
Date Received: 05/31/1988
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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