510(k) K182553
K182553 is an FDA 510(k) premarket notification submitted by Suzhou Innomed Medical Device Co., Ltd. for the device "Inno-Pathwire". The FDA issued a decision of Substantially Equivalent on Mar 11, 2019. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Suzhou Innomed Medical Device Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 2019
- Date Received
- Sep 17, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type
- 510(k)