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

PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS

K Number: K871132 · Decision Apr 20, 1987
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
9
Review Days
31

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Basic Information

Device Name
PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
K Number
K871132
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.1340
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Deltec Systems, Inc.
Date Received
March 20, 1987
Decision Date
April 20, 1987
Product Code
DYB
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
DYB Introducer, Catheter

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Other Clearances by Deltec Systems, Inc.

K Number Device Name
K870768 AC ADAPTER ACCESSORY, PRODUCT CODE 600123A
K862927 CADD-1, MODEL 5100 HF
K854964 CADD-LD 5500 AMBU INFUSION PUMP&3010 10ML MED RES.
K853584 CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP
K850183 CADD-VT, 5300 AMBULATORY INFUSION PUMP W/3050, 50M
K843772 CADD-1 5100 AMBULATORY INFUSION PUMP
K843773 CADD-PAC 5200 AMBULATORY INFUSION PUMP
K833949 MICRO INFUSION SET