FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

DIAGNOSTIC INTRASCULAR CATHETER

K Number: K903848 · Decision Mar 25, 1991
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
21
Review Days
216

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Basic Information

Device Name
DIAGNOSTIC INTRASCULAR CATHETER
K Number
K903848
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Applied Vascular Devices, Inc.
Date Received
August 21, 1990
Decision Date
March 25, 1991
Product Code
DQO
Advisory Committee
Cardiovascular
Review Advisory Committee
CV
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
DQO Catheter, Intravascular, Diagnostic

Similar 510(k) Clearances

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Other Clearances by Applied Vascular Devices, Inc.

K Number Device Name
K911730 SURGICAL OBTURATOR WITH SEAL
K911589 DISPOSABLE SURGICAL TROCAR WITH SEAL
K910339 AVD INTIMAX OCCLUSION CATHETER
K910372 INTIMAX THROMBECTOMY CATHETER
K911181 INTIMAX(TM) IRRIGATION CATHETER
K910493 AVD INTIMAX CHOLANGIOGRAPHY CATHETER
K905738 OPERATIVE CHOLANGIOGRAPHIC CATHETER
K910079 DISPOSABLE INTRODUCER SHEATH
K902256 IRRIGATION CATHETER 4, 6 AND 10 FRENCH
K904379 SURGICAL TROCAR AND CANNULA
Search all 21 clearances from Applied Vascular Devices, Inc. →