The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02
FDA 510(k) K062868 · Flowcardia, Inc.
510(k) numberK062868
Submission
- Device name
- The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02
- Applicant
- Flowcardia, Inc.
Sunnyvale, CA, US - Received
- September 25, 2006
- Decision date
- January 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
Other 510(k)s with product code DQY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260559 | NHanceITDQY · Traditional | IMDS Operation B.V. | 08/14/2026SE |
| K262392 | APRO 35 Swift CatheterDQY · Special | Alembic, LLC | 08/12/2026SE |
| K262240 | SSPC NXT Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261766 | CPS Locator 3D Plus Delivery CatheterDQY · Special | CenterPoint Systems, LLC | 07/29/2026SE |
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | Abbott | 07/02/2026SE |
| K261631 | Amplatzer TorqVue Exchange SystemDQY · Special | Abbott Medical | 06/17/2026SE |
| K260289 | Perfect-O Ostial Positioning CatheterDQY · Traditional | Balosmark, Inc. | 06/05/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | Abbott | 04/24/2026SE |
| K253361 | Teleport Glide MicrocatheterDQY · Traditional | OrbusNeich Medical (Shenzhen) Co., Ltd. | 04/10/2026SE |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/…DQY · Special | Abbott Medical | 03/13/2026SE |
More from Abbott Medical
| 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 |
| K072776 | The Crosser SystemPDU · Traditional | 12/07/2007SE |
| 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 Catheter, Model CR1100 and System Electronics, Model FG1002-02 cleared by the FDA?
The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02 (K062868) received a 510(k) decision of Substantially Equivalent on January 19, 2007, 116 days after the submission was received.
What is the product code of K062868?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.