Scimed Sideliner
FDA 510(k) K922706 · Scimed
510(k) numberK922706
Submission
- Device name
- Scimed Sideliner
- Applicant
- Scimed
Maple Grove, MN, US - Received
- June 5, 1992
- Decision date
- December 10, 1992
- 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
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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 |
| 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 |
|---|---|---|
| K992142 | Scimed Angiographic CathetersDQO · Special | 07/21/1999SE |
| K953909 | Scimed 6 French Micro-Max Guide CatheterDQY · Traditional | 11/13/1995SE |
| K931584 | Scimed Transport Steerable Guide Wire and Access.DQX · Traditional | 07/01/1993SE |
| K915347 | Scimed Viper CatheterLIT · Traditional | 08/17/1992SE |
| K910987 | 7FR. and 8FR. Triguide Guiding Catheter Add. CurveDQO · Traditional | 05/29/1991SE |
| K904171 | Scimed Cardiotherm Cardioplegia Delivery SystemDTR · Traditional | 12/06/1990SE |
| K903503 | Scimed Encore Inflation Device, Model SM2500MAV · Traditional | 10/09/1990SE |
Questions and answers
When was Scimed Sideliner cleared by the FDA?
Scimed Sideliner (K922706) received a 510(k) decision of Substantially Equivalent on December 10, 1992, 188 days after the submission was received.
What is the product code of K922706?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.