Modification to the Crosser System
FDA 510(k) K091119 · Flowcardia, Inc.
510(k) numberK091119
Submission
- Device name
- Modification to the Crosser System
- Applicant
- Flowcardia, Inc.
Sunnyvale, CA, US - Received
- April 17, 2009
- Decision date
- May 15, 2009
- 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.
Other 510(k)s with product code PDU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262013 | Kiba CTO Crossing CatheterPDU · Special | Reflow Medical, Inc. | 08/28/2026SE |
| K252315 | Santreva-ATK Endovascular Revasculariztion CatheterPDU · Traditional | AngioSafe, Inc. | 09/22/2025SE |
| K251158 | PowerWire® 14 Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 09/11/2025SESK |
| K251376 | LimFlow ARCPDU · Special | LimFlow, Inc. | 05/31/2025SE |
| K232562 | PowerWire Radiofrequency Guidewire KitPDU · Traditional | Baylis Medical Technologies, Inc. | 02/28/2024SESK |
| 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 |
|---|---|---|
| K092175 | The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200PDU · Traditional | 02/17/2010SE |
| K090621 | Flowcardia Flowmater Injector, Model Inj 100DXT · Traditional | 06/19/2009SE |
| K091254 | The Crosser 14 Otw Catheter, Model CRU014DQY · Special | 05/29/2009SE |
| K080849 | Microsheath LP and Lp-AtDQY · Traditional | 07/25/2008SE |
| K080765 | Crosser LP SystemDQX · Traditional | 06/20/2008SE |
| K073289 | Microsheath XL CathetersDQY · Traditional | 01/11/2008SE |
| K072776 | The Crosser SystemPDU · Traditional | 12/07/2007SE |
| K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02DQY · Traditional | 01/19/2007SE |
| K051580 | VP SheathDQY · Traditional | 10/31/2005SE |
| K051062 | VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft)…DQX · Traditional | 07/15/2005SE |
Questions and answers
When was Modification to the Crosser System cleared by the FDA?
Modification to the Crosser System (K091119) received a 510(k) decision of Substantially Equivalent on May 15, 2009, 28 days after the submission was received.
What is the product code of K091119?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.