Atlas FDA

Export Advance Aspiration Catheter

FDA 510(k) clearance K152335 · decided 2015-09-18

Clearance details

K-number
K152335
Device name
Export Advance Aspiration Catheter
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2015-08-19
Decision date
2015-09-18
Days to decision
30 days
Clearance type
Special
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Danvers, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Medtronic

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

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

RecordFirmDate
Fogarty Thru-Lumen Embolectomy Catheter (K240078)Edwards Lifesciences, LLC2024-08-28
Fogarty Fortis Arterial Embolectomy Catheter (K241330)Edwards Lifesciences2024-07-02
Fogarty Arterial Embolectomy Catheter with Gate Valve (K233820)Edwards Lifesciences2024-05-22
Fogarty Venous Thrombectomy Catheters (K233819)Edwards Lifesciences, LLC2024-05-22
Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (K233619)Edwards Lifesciences2024-05-20
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
Needle's Eye Snare Retrieval Set - 54cm (K163353)Cook Incorporated2017-07-11
EMBO PLUS EMBOLECTOMY CATHETER (K100840)Hotspur Technologies2010-07-12
PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM (K100842)Hotspur Technologies2010-07-12

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SynchroMed Infusion System; Ascenda Intrathecal Catheters (P860004/S455)Medtronic, Inc.2025-12-22
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (P960009/S527)Medtronic, Inc.2025-12-22
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol (P010015/S574)Medtronic, Inc.2025-12-19
SynchroMed™ Infusion Systems (P860004/S453)Medtronic, Inc.2025-12-19
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (P960009/S526)Medtronic, Inc.2025-12-18
Activa™ Deep Brain Stimulation Therapy System (P960009/S514)Medtronic, Inc.2025-12-17
Aurora EV-ICD System (P220012/S061)Medtronic, Inc.2025-12-15
Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08