Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid
FDA 510(k) K964551 · Scimed Life Systems, Inc.
510(k) numberK964551
Submission
- Device name
- Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid
- Applicant
- Scimed Life Systems, Inc.
Maple Grove, MN, US - Received
- November 13, 1996
- Decision date
- May 21, 1997
- 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 |
| 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 |
| K964859 | Scimed 5 French Impulse Angiographic CathetersDQO · Traditional | 02/10/1997SE |
Questions and answers
When was Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid cleared by the FDA?
Choice Super Support Ptca Guide Wire, Choice Plus Super Support Ptca Guide Wire, Choice Exchange Super Support Ptca Guid (K964551) received a 510(k) decision of Substantially Equivalent on May 21, 1997, 189 days after the submission was received.
What is the product code of K964551?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.