Atlas FDA

DUAL LUMEN EMBOLECTOMY CATHETER

FDA 510(k) clearance K970762 · decided 1997-03-28

Clearance details

K-number
K970762
Device name
DUAL LUMEN EMBOLECTOMY CATHETER
Applicant
Applied Medical Resources
Decision
Substantially Equivalent
Date received
1997-03-03
Decision date
1997-03-28
Days to decision
25 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Launa Hills, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A recall (Z-1846-2020)Applied Medical Resources Corp2020-05-07
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; C recall (Z-1847-2020)Applied Medical Resources Corp2020-05-07