Atlas FDA

ANGIOSCOPY CATHETER

FDA 510(k) clearance K834547 · decided 1984-06-11

Clearance details

K-number
K834547
Device name
ANGIOSCOPY CATHETER
Applicant
American Edwards Laboratories
Decision
Substantially Equivalent
Date received
1983-12-27
Decision date
1984-06-11
Days to decision
167 days
Clearance type
Traditional
Product code
LYK
Device class
2
Regulation number
876.1500
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GARREN GASTRIC BUBBLE (P840025/S011)American Edwards Laboratories1987-03-17
GARREN GASTRIC BUBBLE (P840025/S008)American Edwards Laboratories1986-10-16
GARREN GASTRIC BUBBLE (P840025/S006)American Edwards Laboratories1986-07-25
GARREN{TM}-EDWARDS GASTRIC BUBBLE (P840025/S005)American Edwards Laboratories1986-05-12
GARREN GASTRIC BUBBLE (P840025/S003)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S002)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S004)American Edwards Laboratories1986-01-23
GARREN GASTRIC BUBBLE (P840025/S001)American Edwards Laboratories1985-12-18