Guidewires
FDA 510(k) K042264 · Rocket Medical Plc
510(k) numberK042264
Submission
- Device name
- Guidewires
- Applicant
- Rocket Medical Plc
Washington, Tyne & Wear, GB - Received
- August 23, 2004
- Decision date
- November 24, 2004
- 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 |
|---|---|---|
| K210509 | Rocket Platinum Cured CathterDWM · Traditional | 09/09/2021SESK |
| K163321 | Rocket Indwelling Pleural Catheter (IPC) Insertion KitDWM · Traditional | 08/17/2017SE |
| K162457 | Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitPNG · Traditional | 11/14/2016SEKD |
| K152105 | Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetPNG · Traditional | 03/29/2016SESK |
| K123033 | Rocket Ipc Insertion Pack, Rocket Ipc Mini Insertion Set, Rocket Ipc Dressing Pack and…DWM · Traditional | 02/01/2013SE |
| K052365 | Cervineedle Disposable Cartridge SyringeHEE · Traditional | 10/17/2005SE |
| K040189 | Endometrial Sampling SyringeHHK · Traditional | 10/04/2004SE |
| K032015 | Embryon Ultrasound Needle GuideMQE · Traditional | 08/08/2003SE |
| K000340 | Hystalog HSG CatheterHES · Traditional | 04/19/2000SE |
| K000205 | Embryon Single and Double Lumen NeedlesMQE · Traditional | 04/19/2000SE |
Questions and answers
When was Guidewires cleared by the FDA?
Guidewires (K042264) received a 510(k) decision of Substantially Equivalent on November 24, 2004, 93 days after the submission was received.
What is the product code of K042264?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.