Inno-Hydrowire
FDA 510(k) K172187 · Suzhou Innomed Medical Device Co., Ltd.
510(k) numberK172187
Submission
- Device name
- Inno-Hydrowire
- Applicant
- Suzhou Innomed Medical Device Co., Ltd.
Suzhou, CN - Received
- July 20, 2017
- Decision date
- April 11, 2018
- 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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| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
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| 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 |
|---|---|---|
| K182553 | Inno-PathwireDQX · Traditional | 03/11/2019SE |
Questions and answers
When was Inno-Hydrowire cleared by the FDA?
Inno-Hydrowire (K172187) received a 510(k) decision of Substantially Equivalent on April 11, 2018, 265 days after the submission was received.
What is the product code of K172187?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.