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

HELI-TECH RETRIEVAL BASKET

K Number: K926040 · Decision Dec 23, 1992
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
36
Applicant Total
3
Review Days
22

Basic Information

Device Name
HELI-TECH RETRIEVAL BASKET
K Number
K926040
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
876.5010
Medical Specialty
Gastroenterology, Urology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
CAPE TECH MEDICAL PRODUCTS
Date Received
December 1, 1992
Decision Date
December 23, 1992
Product Code
LQR
Advisory Committee
Gastroenterology, Urology
Review Advisory Committee
GU
Third Party
N

Classifications

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

Product Code Device Name
LQR Dislodger, Stone, Biliary

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Other Clearances by CAPE TECH MEDICAL PRODUCTS

K Number Device Name
K926038 FLEX-TECH BALLOON DILATOR
K926039 GUIDE-TECH ENCAPSULATED GUIDEWIRE