Pre-Formed Blue
FDA 510(k) K221575 · Lake Region Medical
510(k) numberK221575
Submission
- Device name
- Pre-Formed Blue
- Applicant
- Lake Region Medical
Chaska, MN, US - Received
- June 1, 2022
- Decision date
- October 7, 2022
- 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 |
|---|---|---|
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | 03/19/2026SE |
| K242824 | PTFE GuidewireDQX · Special | 12/06/2024SE |
| K211741 | Pre-Formed Extra Support GuidewireDQX · Traditional | 11/22/2021SE |
| K160643 | ENROUTE 0.014 GuidewireDQX · Traditional | 10/18/2016SE |
| K151244 | Pre-Formed GuidewireDQX · Special | 06/11/2015SE |
| K140536 | Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250T…DQX · Traditional | 12/17/2014SE |
| K142393 | Predicate III GuidewireDQX · Special | 11/25/2014SE |
| K142397 | Predicate III GuidewireOCY · Special | 09/19/2014SE |
| K140482 | Mandrel GuidewireOCY · Special | 04/08/2014SE |
| K133155 | Hydrophilic Coated GuidewireDQX · Traditional | 04/07/2014SE |
Questions and answers
When was Pre-Formed Blue cleared by the FDA?
Pre-Formed Blue (K221575) received a 510(k) decision of Substantially Equivalent on October 7, 2022, 128 days after the submission was received.
What is the product code of K221575?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.