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

P-S BERLIN VESSEL CLAMP

K Number: K820949 · Decision Apr 29, 1982
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
40
Review Days
23

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Basic Information

Device Name
P-S BERLIN VESSEL CLAMP
K Number
K820949
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
870.4450
Medical Specialty
Cardiovascular
Decision
Substantially Equivalent
Applicant
Pudenz-Schulte Medical Research Corp.
Date Received
April 6, 1982
Decision Date
April 29, 1982
Product Code
DXC
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
DXC Clamp, Vascular

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K951258 PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT
K934796 IPI LOW PROFILE IMPORT
K934167 IPI DUAL LUMEN PORT
K940096 PS MEDICAL CATHETER PLACEMENT KIT
K934545 PS MEDICAL DELTA BURR HOLE VALVE
K930206 PS MEDICAL IPI ACCESS KIT
K930606 PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER
K913412 PS MEDICAL CSF-ACCESS DEVICE
Search all 40 clearances from Pudenz-Schulte Medical Research Corp. →