Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]
FDA 510(k) K050916 · Intra Luminal Therapeutics, Inc.
510(k) numberK050916
Submission
- Device name
- Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral]
- Applicant
- Intra Luminal Therapeutics, Inc.
Carlsbad, CA, US - Received
- April 12, 2005
- Decision date
- June 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PDU – Catheter For Crossing Total Occlusions
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
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| K251158 | PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 09/11/2025SESK |
| K251376 | LimFlow ARCPDU · Special | LimFlow, Inc. | 05/31/2025SE |
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| K230159 | SoundBite® Crossing System XS PeripheralPDU · Traditional | Soundbite Medical Solutions, Inc. | 08/28/2023SE |
| K230594 | Tigereye ST CTO-Crossing CatheterPDU · Traditional | Avinger, Inc. | 04/25/2023SE |
| K221163 | Tunnel Crossing CatheterPDU · Traditional | Tractus Vascular, LLC | 01/19/2023SE |
| K221541 | LimFlow ARCPDU · Traditional | LimFlow, Inc. | 08/31/2022SE |
| K220544 | DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)PDU · Traditional | Ra Medical Systems,Inc | 06/29/2022SE |
More from Ra Medical Systems,Inc
| 510(k) | Device | Decision |
|---|---|---|
| K050915 | Safe-Cross Radio Frequency Total Occlusion Crossing System [Coronary]DQX · Special | 06/07/2005SE |
| K041973 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 08/16/2004SE |
| K040481 | Safe-Cross Deflecting Catheter, Model C118ND1DQY · Special | 03/18/2004SE |
| K040037 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 03/03/2004SE |
| K033929 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 01/12/2004SE |
| K032031 | Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Traditional | 01/07/2004SE |
| K033708 | Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemDQX · Special | 12/11/2003SE |
| K031842 | Safe-Cross Radio Frequency Total Occlusion Crossing SystemPDU · Traditional | 11/21/2003SE |
| K032784 | Ilt Safe-Cross Deflecting Catheter, Model C114ND1DQY · Traditional | 11/18/2003SE |
| K031692 | Safe-Cross Deflecting Catheter, Model C114ND1DQY · Traditional | 08/22/2003SE |
Questions and answers
When was Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral] cleared by the FDA?
Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral] (K050916) received a 510(k) decision of Substantially Equivalent on June 8, 2005, 57 days after the submission was received.
What is the product code of K050916?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.