The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Pacific Plus.
Device ID | K123358 |
510k Number | K123358 |
Device Name: | PACIFIC PLUS |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
Contact | Diana Johnson |
Correspondent | Diana Johnson MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-31 |
Decision Date | 2013-01-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PACIFIC PLUS 74147189 not registered Dead/Abandoned |
Pacific First Bank, a Federal Savings Bank 1991-03-11 |