510(k) K191502
K191502 is an FDA 510(k) premarket notification submitted by Heraeus Medical Components, LLC for the device "Heraeus Peripheral Guidewire". The FDA issued a decision of Substantially Equivalent on Nov 26, 2019. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Heraeus Medical Components, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 26, 2019
- Date Received
- Jun 6, 2019
- 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)