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FDA 510(k) Applications Submitted by CARDIOVASCULAR DYNAMICS, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K963688
09/16/1996
FOCUS PV BALLOON DILATATION CATHETER
CARDIOVASCULAR DYNAMICS, INC.
K963989
10/04/1996
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
CARDIOVASCULAR DYNAMICS, INC.
K971577
04/21/1997
FOCUS-PV BALLOON DILATATION CATHETER
CARDIOVASCULAR DYNAMICS, INC.
K973713
09/29/1997
22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR
CARDIOVASCULAR DYNAMICS, INC.
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