Vascupuncture Access Wire
FDA 510(k) K012861 · Neometrics, Inc.
510(k) numberK012861
Submission
- Device name
- Vascupuncture Access Wire
- Applicant
- Neometrics, Inc.
Minneapolis, MN, US - Received
- August 24, 2001
- Decision date
- February 5, 2002
- 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
Other 510(k)s with product code DQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K152560 | Bard Snare Retrieval KitMMX · Traditional | 10/23/2015SE |
| K150225 | NovaGold High Performance GuidewireOCY · Traditional | 03/16/2015SE |
| K143135 | Spring Coil GuidewireDQX · Traditional | 02/20/2015SE |
| K133076 | Novagold High Performance GuidewireOCY · Traditional | 02/20/2014SE |
| K123439 | Neo Ercp GuidewireOCY · Traditional | 01/03/2013SE |
| K101729 | Neowire Pta/Ptca GuidewireDQX · Traditional | 09/23/2010SE |
| K070150 | Vascupuncture Picc GuidewireDQX · Special | 02/15/2007SE |
| K043398 | Modification to Vascupuncture Picc GuidewireDQX · Special | 03/01/2005SE |
| K040786 | Vascupuncture Picc Guidewire with Hydro-Silk CoatingDQX · Special | 04/19/2004SE |
| K033321 | Selectiva SB GuidewireDQX · Special | 11/05/2003SE |
Questions and answers
When was Vascupuncture Access Wire cleared by the FDA?
Vascupuncture Access Wire (K012861) received a 510(k) decision of Substantially Equivalent on February 5, 2002, 165 days after the submission was received.
What is the product code of K012861?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.