The following data is part of a premarket notification filed by Cardinal Health with the FDA for Temporary Titanium Aneurysm Clip.
Device ID | K031468 |
510k Number | K031468 |
Device Name: | TEMPORARY TITANIUM ANEURYSM CLIP |
Classification | Clip, Aneurysm |
Applicant | Cardinal Health 1500 WAUKEGAN ROAD, BLDG. WM Mcgaw Park, IL |
Contact | Lance Macrconi |
Correspondent | Lance Macrconi Cardinal Health 1500 WAUKEGAN ROAD, BLDG. WM Mcgaw Park, IL |
Product Code | HCH |
CFR Regulation Number | 882.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-09 |
Decision Date | 2003-06-20 |
Summary: | summary |