The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Prelude Sheath Introducer.
Device ID | K050962 |
510k Number | K050962 |
Device Name: | MERIT PRELUDE SHEATH INTRODUCER |
Classification | Dilator, Vessel, For Percutaneous Catheterization |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Contact | Jerrie Hendrickson |
Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
Product Code | DRE |
CFR Regulation Number | 870.1310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2005-04-18 |
Decision Date | 2005-05-06 |
Summary: | summary |