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FDA 510(k), K042937, MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
FDA 510(k), K042937, MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
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510(K) Number: K042937
Device Name: MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
Manufacturer: DEBORAH L NEYMARK
Device Classification Name: Aspiration Thrombectomy Catheter
Regulation Number: QEZ
Classification Product Code: KXA
Date Received: 10/25/2004
Decision Date: 01/31/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: MODIFICATION TO VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
Manufacturer: DEBORAH L NEYMARK
Device Classification Name: Aspiration Thrombectomy Catheter
Regulation Number: QEZ
Classification Product Code: KXA
Date Received: 10/25/2004
Decision Date: 01/31/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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