Atlas FDA

EkoSonic Endovascular Device, EKOS+ Endovascular Device

FDA 510(k) clearance K213422 · decided 2021-12-14

Clearance details

K-number
K213422
Device name
EkoSonic Endovascular Device, EKOS+ Endovascular Device
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2021-10-20
Decision date
2021-12-14
Days to decision
55 days
Clearance type
Traditional
Product code
QEY
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
Versus™ Catheter (VS110-9NB) (K260149)Liquet Medical, Inc.2026-02-17
VariFuse Adjustable Infusion Catheter (K251318)Argon Medical Devices, Inc.2026-01-20
Versus™ Catheter (VS110-8B) (K241851)Liquet Medical, Inc.2024-11-25
BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter (K231653)Thrombolex, Inc.2023-07-03
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 (K222095)Thrombolex, Inc.2023-04-20
EKOS+ Endovascular Device (K220866)Boston Scientific2022-04-20
EkoSonic Endovascular Device (K211080)Boston Scientific2021-11-19
BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) (K211061)Thrombolex, Inc.2021-06-10
UNIFUSE Infusion System with Cooper Wire (K202347)AngioDynamics, Inc.2020-09-15
EKOS PE Endovascular Device with Control System 4.0 (CS4.0) (K200648)Ekos Corporation2020-08-17
UNI*FUSE Infusion System with Cooper Wire (K192864)AngioDynamics, Inc.2020-06-01
Bashir Plus Endovascular Catheter (K193071)Thrombolex, Inc.2019-12-17

Recalls involving this device

No recalls on record reference this clearance.

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