510(k) K060422
- Device
- LYSUS INFUSION SYSTEM
- Applicant
- EKOS CORP.
- 510(k) number
- K060422
- Product code
- QEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-03-09
- Date received
- 2006-02-17
- Regulation
- 870.5150
- Classification name
- Mechanical Thrombolysis Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOCELYN KERSTEN
- Address
- 22030 20th Ave. SE Suite 101 Bothell WA US 98021 98021
FDA Registration Numbers#
- 1000523114
- 1721676
- 3003678543
- 2134265
- 9616662
- 3002807314
- 9681260
- 3015309643
- 3038791046
- 3012536737
- 1000121056
- 2246552
- 1319211
- 3010273872
- 3007695959
- 1724474
- 3033589330
- 3027595864
- 3015489145
- 3015225571
- 1721504
- 2124215
- 3006950086
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 |
| K211080 | EkoSonic Endovascular Device | Boston Scientific | 2021-11-19 |
| 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 |
Legacy Summary#
summary
FDA Review#
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