Uresil(R) Guidewire
FDA 510(k) K945934 · Uresil Corp.
510(k) numberK945934
Submission
- Device name
- Uresil(R) Guidewire
- Applicant
- Uresil Corp.
Skokie, IL, US - Received
- December 5, 1994
- Decision date
- July 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K093653 | Uresil Gastrostomy Catheter Kit , Model GCL-630HBKKNT · Traditional | 02/23/2010SESK |
| K053245 | GP General Purpose Drainage Catheter; Mini-Pig Drainage Catheter; Nephrostomy Catheter…FGE · Special | 12/20/2005SE |
| K041995 | Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter…GBO · Special | 08/19/2004SE |
| K003753 | GP General Purpose Drainage Set, Mini-Pigtail Drainage Catheter with Locking Pigtail, GP…FGE · Special | 01/04/2001SE |
| K980278 | Uresil Vascu-Flo Infusion CatheterDQY · Traditional | 11/20/1998SE |
| K981344 | Uresil Percutaneous Drainage Catheters with Hydrophilic CoatingLJE · Traditional | 09/10/1998SE |
| K980282 | Uresil Dilator with Radiopaque MarkerDRE · Traditional | 04/24/1998SE |
| K980889 | Uresil Nephro-Ureteral StentLJE · Traditional | 04/08/1998SE |
| K972582 | Uresil GuidewireFGE · Traditional | 11/21/1997SE |
| K972583 | Uresil General Purpose Drainage Catheter, Uresil Nephrostomy Catheter, Uresil Biliary…FGE · Traditional | 08/29/1997SE |
Questions and answers
When was Uresil(R) Guidewire cleared by the FDA?
Uresil(R) Guidewire (K945934) received a 510(k) decision of Substantially Equivalent on July 10, 1995, 217 days after the submission was received.
What is the product code of K945934?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.