Atlas FDA

EMBOLECTOMY CATHETER(MODIFIED)

FDA 510(k) clearance K881455 · decided 1988-06-15

Clearance details

K-number
K881455
Device name
EMBOLECTOMY CATHETER(MODIFIED)
Applicant
Cathlab Corp.
Decision
Substantially Equivalent
Date received
1988-04-06
Decision date
1988-06-15
Days to decision
70 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Tustin, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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Merlin Aspiration System (K213771)Mivi Neurovascular, Inc.2022-01-27
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (K202049)Applied Medical Resources Corporation2021-09-07
Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (K193379)Edwards Lifesciences, LLC2020-06-12
Bunegin-Albin Air Aspiration Set (K163031)Cook Incorporated2017-07-27
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Export Advance Aspiration Catheter (K152335)Medtronic, Inc.2015-09-18
EMBO PLUS EMBOLECTOMY CATHETER (K100840)Hotspur Technologies2010-07-12

Recalls involving this device

No recalls on record reference this clearance.