Atlas FDA

FOGARTY FLEXIBLE PROBE

FDA 510(k) clearance K812935 · decided 1981-11-16

Clearance details

K-number
K812935
Device name
FOGARTY FLEXIBLE PROBE
Applicant
American Edwards Laboratories
Decision
Substantially Equivalent
Date received
1981-10-20
Decision date
1981-11-16
Days to decision
27 days
Clearance type
Traditional
Product code
DWP
Device class
2
Regulation number
870.4475
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Walker, MI, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS (K030788)Geister Medizin Technik GmbH2003-07-12
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
ROBICSEK PROBE/RETRACTOR (K910682)Bio-Vascular, Inc.1991-05-08
FLO-RESTER(R) VESSEL SIZER (K905159)Bio-Vascular, Inc.1991-02-07
FOGARTY VESSEL CALIBRATOR (K902143)Baxter Healthcare Corp1990-10-16

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