MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
FDA 510(k) K173423 · Nano4imaging GmbH
510(k) numberK173423
Submission
- Device name
- MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
- Applicant
- Nano4imaging GmbH
Aachen, DE - Received
- November 1, 2017
- Decision date
- November 17, 2017
- 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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| 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 |
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Questions and answers
When was MR Wire Guide Wire Straight, MR Wire Guide Wire Angled cleared by the FDA?
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled (K173423) received a 510(k) decision of Substantially Equivalent on November 17, 2017, 16 days after the submission was received.
What is the product code of K173423?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.