The following data is part of a premarket notification filed by Heraeus Medical Components, Llc with the FDA for Heraeus Peripheral Guidewire.
Device ID | K191502 |
510k Number | K191502 |
Device Name: | Heraeus Peripheral Guidewire |
Classification | Wire, Guide, Catheter |
Applicant | Heraeus Medical Components, LLC 2605 Fernbrook Lane North, Suite J Plymouth, MN 55447 |
Contact | Chelsea Pioske |
Correspondent | Chelsea Pioske Heraeus Medical Components, LLC 2605 Fernbrook Lane North, Suite J Plymouth, MN 55447 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-06 |
Decision Date | 2019-11-26 |
Summary: | summary |