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510(k) K993816

BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD by Baxter Edwards — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2000
Date Received
November 10, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

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