Atlas FDA

FOGARTY FLEXIBLE CALIBRATOR

FDA 510(k) clearance K810894 · decided 1981-05-15

Clearance details

K-number
K810894
Device name
FOGARTY FLEXIBLE CALIBRATOR
Applicant
American Edwards Laboratories
Decision
Substantially Equivalent
Date received
1981-04-03
Decision date
1981-05-15
Days to decision
42 days
Clearance type
Traditional
Product code
DWP
Device class
2
Regulation number
870.4475
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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RDI CARDIAC INSULATION PAD (K960312)R D Intl.1996-04-19
LEMAITRE-BOOKWALTER VESSEL DEVICES (K912548)Vascutech, Inc.1991-09-18
LAPAROSCOPIC VESSEL ARTICULATOR (K911475)United States Endoscopy Group, Inc.1991-07-02
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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