The Crosser System
FDA 510(k) K072776 · Flowcardia, Inc.
510(k) numberK072776
Submission
- Device name
- The Crosser System
- Applicant
- Flowcardia, Inc.
Sunnyvale, CA, US - Received
- September 28, 2007
- Decision date
- December 7, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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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 |
| K091119 | Modification to the Crosser SystemPDU · Special | 05/15/2009SE |
| 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 |
| 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 The Crosser System cleared by the FDA?
The Crosser System (K072776) received a 510(k) decision of Substantially Equivalent on December 7, 2007, 70 days after the submission was received.
What is the product code of K072776?
The FDA product code is PDU – Catheter For Crossing Total Occlusions, a Class II (moderate risk) device regulated under 21 CFR 870.1250.