Atlas FDA

NEPHROSTOMY GUIDEWIRE SHEATH

FDA 510(k) clearance K845047 · decided 1985-01-15

Clearance details

K-number
K845047
Device name
NEPHROSTOMY GUIDEWIRE SHEATH
Applicant
American Edwards Laboratories
Decision
Substantially Equivalent
Date received
1984-12-31
Decision date
1985-01-15
Days to decision
15 days
Clearance type
Traditional
Product code
LJE
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Santa Ana, CA, 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