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

CODMAN SUCTION PATTIE

K Number: K901937 · Decision Jul 16, 1990
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
152
Review Days
77

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Basic Information

Device Name
CODMAN SUCTION PATTIE
K Number
K901937
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.6740
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Codman & Shurtleff, Inc.
Date Received
April 30, 1990
Decision Date
July 16, 1990
Product Code
GCX
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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K173192 CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
K172537 Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K172022 CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K171862 GALAXY G3 Mini Microcoil Delivery System
K171747 MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
K171653 YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up
K162563 YOGA Microcatheter
K162437 Codman EDS3 CSF External Drainage System
Search all 152 clearances from Codman & Shurtleff, Inc. →