510(k) K210664
- Device
- DABRA Laser System (DABRA Laser Model RA-308 And DABRA Catheter Model 101)
- Applicant
- Ra Medical Systems, Inc.
- 510(k) number
- K210664
- Product code
- PDU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-07-27
- Date received
- 2021-03-05
- Regulation
- 870.1250
- Classification name
- Catheter For Crossing Total Occlusions
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jami Miller
- Address
- 2070 Las Palmas Dr. Carlsbad CA US 92011 92011
FDA Registration Numbers#
- 1722746
- 1221485
- 2183744
- 3008998256
- 3008729892
- 3013757884
- 3007284006
- 1313046
- 3009882464
- 2528981
- 3023527320
- 3009561706
- 2183870
- 3005580113
- 3008363989
- 2939520
- 1450662
- 3003637635
- 2030598
- 3010273872
- 3009128730
- 3009018440
- 3002807314
- 3030446844
- 3020968442
- 9616099
- 2020394
- 1016427
- 1721676
- 3009039068
- 1724474
- 3027058844
- 1643817
- 2011171
- 1820334
- 3006082230
- 1319639
- 2126666
- 1018233
- 3000126629
- 3008789872
- 3038165043
Source Documents#
Other 510(k) Records For Product Code PDU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252315 | Santreva™-ATK Endovascular Revasculariztion Catheter | AngioSafe, Inc. | 2025-09-22 |
| K251158 | PowerWire® 14 Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2025-09-11 |
| K251376 | LimFlow ARC | LimFlow, Inc. | 2025-05-31 |
| K232562 | PowerWire Radiofrequency Guidewire Kit | Baylis Medical Technologies, Inc. | 2024-02-28 |
| K230159 | SoundBite® Crossing System XS Peripheral | Soundbite Medical Solutions, Inc. | 2023-08-28 |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | 2023-04-25 |
| K221163 | Tunnel Crossing Catheter | Tractus Vascular, LLC | 2023-01-19 |
| K221541 | LimFlow ARC | LimFlow, Inc. | 2022-08-31 |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) | Ra Medical Systems,Inc | 2022-06-29 |
| K211802 | GoBack Crossing Catheter | Upstream Peripheral Technologies, Ltd. | 2022-03-01 |
| K212468 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2022-01-06 |
| K203363 | Crosser iQ CTO Recanalization System | C.R. Bard, Inc. | 2021-08-12 |
| K210839 | SoundBite Crossing System - Peripheral (14P) | Soundbite Medical Solutions, Inc. | 2021-04-20 |
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2020-09-10 |
| K192211 | SoundBite Console, SoundBite Active Wire 18 | Soundbite Medical Solution, Inc. | 2020-01-17 |
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