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

ANGIO WASTE FLUIDS DUMP BAG

K Number: K874037 · Decision Jan 29, 1988
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
16
Review Days
116

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Basic Information

Device Name
ANGIO WASTE FLUIDS DUMP BAG
K Number
K874037
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1200
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Procedure Products, Inc.
Date Received
October 5, 1987
Decision Date
January 29, 1988
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

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Other Clearances by Procedure Products, Inc.

K Number Device Name
K161812 Freedom Syringe
K923194 INSUFFLATOR CONNECTING FILTER
K922536 TORQUE DEVICE
K914128 CONNECTING SET
K910673 BAG SPIGOT
K884985 MODIFIED 10CC SYRINGE CONTROL RING SET
K874747 10CC SYRINGE CONTROL RING SET
K853749 CUSTOM CORONARY MANIFOLD KITS
K842173 DISPOSABLE STOPCOCKS
K833554 MATERIAL ADDITION LEXAN & K-RESIN
Search all 16 clearances from Procedure Products, Inc. →