The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Prelude And Prelude Pro Sheath Introducers.
Device ID | K073035 |
510k Number | K073035 |
Device Name: | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS |
Classification | Dilator, Vessel, For Percutaneous Catheterization |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Contact | Shirley Hyink |
Correspondent | Shirley Hyink MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Product Code | DRE |
CFR Regulation Number | 870.1310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-10-29 |
Decision Date | 2007-11-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884450054342 | K073035 | 000 |
10884450015299 | K073035 | 000 |
20884450331112 | K073035 | 000 |