Lunderquist Extra Stiff Wire Guide
FDA 510(k) K220137 · William Cook Europe Aps
510(k) numberK220137
Submission
- Device name
- Lunderquist Extra Stiff Wire Guide
- Applicant
- William Cook Europe Aps
Bjaeverskov, DK - Received
- January 18, 2022
- Decision date
- February 17, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 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 |
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| 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 |
|---|---|---|
| K251596 | Lunderquist Extra Stiff Wire GuideDQX · Special | 11/09/2025SE |
| K251499 | Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer…BTR · Special | 06/11/2025SE |
| K233680 | Celect Platinum Vena Cava Filter Set for Femoral Vein Approach…DTK · Traditional | 01/18/2024SE |
| K211875 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Special | 07/28/2021SE |
| K211874 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Special | 07/28/2021SE |
| K171513 | Lunderquist Extra Stiff Wire GuideDQX · Traditional | 12/07/2017SE |
| K172584 | Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava…DTK · Traditional | 11/20/2017SE |
| K172557 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava…DTK · Traditional | 11/20/2017SE |
| K171712 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect…DTK · Traditional | 08/07/2017SE |
| K161813 | Frova Intubating IntroducerBTR · Traditional | 05/19/2017SE |
Questions and answers
When was Lunderquist Extra Stiff Wire Guide cleared by the FDA?
Lunderquist Extra Stiff Wire Guide (K220137) received a 510(k) decision of Substantially Equivalent on February 17, 2022, 30 days after the submission was received.
What is the product code of K220137?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.