510(k) K211080
- Device
- EkoSonic Endovascular Device
- Applicant
- Boston Scientific
- 510(k) number
- K211080
- Product code
- QEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-19
- Date received
- 2021-04-12
- Regulation
- 870.5150
- Classification name
- Mechanical Thrombolysis Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joshua Kim
- Address
- Two Scimed Pl. Maple Grove MN US 55311 55311
FDA Registration Numbers#
- 3027595864
- 2134265
- 3015489145
- 3007695959
- 3015309643
- 3038791046
- 3006950086
- 2246552
- 3010273872
- 3033589330
- 2124215
- 3002807314
- 1721676
- 1721504
- 1000121056
- 1319211
- 1724474
- 9616662
- 3015225571
- 3012536737
- 3003678543
- 9681260
- 1000523114
Source Documents#
Other 510(k) Records For Product Code QEY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260149 | Versus™ Catheter (VS110-9NB) | Liquet Medical, Inc. | 2026-02-17 |
| K251318 | VariFuse Adjustable Infusion Catheter | Argon Medical Devices, Inc. | 2026-01-20 |
| K241851 | Versus™ Catheter (VS110-8B) | Liquet Medical, Inc. | 2024-11-25 |
| K231653 | BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter | Thrombolex, Inc. | 2023-07-03 |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2023-04-20 |
| K220866 | EKOS+ Endovascular Device | Boston Scientific | 2022-04-20 |
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device | Boston Scientific Corporation | 2021-12-14 |
| K211061 | 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) | Thrombolex, Inc. | 2021-06-10 |
| K202347 | UNIFUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-09-15 |
| K200648 | EKOS PE Endovascular Device with Control System 4.0 (CS4.0) | Ekos Corporation | 2020-08-17 |
| K192864 | UNI*FUSE Infusion System with Cooper Wire | AngioDynamics, Inc. | 2020-06-01 |
| K193071 | Bashir Plus Endovascular Catheter | Thrombolex, Inc. | 2019-12-17 |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | Thrombolex, Inc. | 2019-10-18 |
| K191119 | EkoSonic Endovascular Device | Btg International, Inc. | 2019-08-23 |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | Btg International, Inc. | 2019-04-05 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases