VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft) Model GW140SO
FDA 510(k) K051062 · Flowcardia, Inc.
510(k) numberK051062
Submission
- Device name
- VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft) Model GW140SO
- Applicant
- Flowcardia, Inc.
Sunnyvale, CA, US - Received
- April 26, 2005
- Decision date
- July 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, 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 |
| 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 |
Questions and answers
When was VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft) Model GW140SO cleared by the FDA?
VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft) Model GW140SO (K051062) received a 510(k) decision of Substantially Equivalent on July 15, 2005, 80 days after the submission was received.
What is the product code of K051062?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.