PINNACLE PRECISION ACCESS SYSTEM
Introducer, Catheter
TERUMO MEDICAL CORP.
The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Pinnacle Precision Access System.
Pre-market Notification Details
| Device ID | K111606 |
| 510k Number | K111606 |
| Device Name: | PINNACLE PRECISION ACCESS SYSTEM |
| Classification | Introducer, Catheter |
| Applicant | TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Contact | Daniel R Plonski |
| Correspondent | Daniel R Plonski TERUMO MEDICAL CORP. 950 Elkton Blvd. Elkton, MD 21921 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-09 |
| Decision Date | 2011-10-03 |
| Summary: | summary |
Trademark Results [PINNACLE PRECISION ACCESS SYSTEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PINNACLE PRECISION ACCESS SYSTEM 85368042 4276564 Live/Registered |
Terumo Kabushiki Kaisha (Terumo Corporation) 2011-07-11 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.