Scimed(R) Choice(Tm) PT Exchange Ptca Guide Wire
FDA 510(k) K950266 · Scimed Life Systems, Inc.
510(k) numberK950266
Submission
- Device name
- Scimed(R) Choice(Tm) PT Exchange Ptca Guide Wire
- Applicant
- Scimed Life Systems, Inc.
Plymouth, MN, US - Received
- January 23, 1995
- Decision date
- April 14, 1995
- 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 |
|---|---|---|
| K974241 | Scimed Informer Pressure Wire SystemDQX · Traditional | 11/12/1998SE |
| K981788 | Scimed 6 French Wiseguide Guide CatheterDQO · Traditional | 08/18/1998SE |
| K980360 | Scimed Quest Floppy and Moderate Support Guide WiresDQX · Traditional | 04/29/1998SE |
| K974559 | Scimed 6 French Impulse Angiographic CathetersDQO · Traditional | 02/23/1998SE |
| K974684 | Scimed 7 French Wiseguide Guide CatheterDQY · Traditional | 02/19/1998SE |
| K973945 | Luge Guide WireDQX · Traditional | 01/12/1998SE |
| K970823 | Scimed 8 French Wiseguide Guide CatheterDQY · Traditional | 06/03/1997SE |
| K964551 | Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice…DQX · Traditional | 05/21/1997SE |
| K970244 | Scimed Choice Family of Ptca Guide WiresDQX · Traditional | 03/28/1997SE |
| K965023 | Choice PT Plus Ptca Guide Wire and Choice PT Vision Ptca Guide WireDQX · Traditional | 03/04/1997SE |
Questions and answers
When was Scimed(R) Choice(Tm) PT Exchange Ptca Guide Wire cleared by the FDA?
Scimed(R) Choice(Tm) PT Exchange Ptca Guide Wire (K950266) received a 510(k) decision of Substantially Equivalent on April 14, 1995, 81 days after the submission was received.
What is the product code of K950266?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.