Inno-Pathwire
FDA 510(k) K182553 · Suzhou Innomed Medical Device Co., Ltd.
510(k) numberK182553
Submission
- Device name
- Inno-Pathwire
- Applicant
- Suzhou Innomed Medical Device Co., Ltd.
Suzhou, CN - Received
- September 17, 2018
- Decision date
- March 11, 2019
- 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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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172187 | Inno-HydrowireDQX · Traditional | 04/11/2018SE |
Questions and answers
When was Inno-Pathwire cleared by the FDA?
Inno-Pathwire (K182553) received a 510(k) decision of Substantially Equivalent on March 11, 2019, 175 days after the submission was received.
What is the product code of K182553?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.