The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Progreat.
| Device ID | K033583 |
| 510k Number | K033583 |
| Device Name: | PROGREAT |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Mark Unterreiner |
| Correspondent | Mark Unterreiner TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-13 |
| Decision Date | 2003-12-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROGREAT 87570127 5418190 Live/Registered |
Terumo Kabushiki Kaisha 2017-08-15 |
![]() PROGREAT 78514677 3097500 Live/Registered |
Terumo Kabushiki Kaisha 2004-11-10 |
![]() PROGREAT 76412503 not registered Dead/Abandoned |
Tsubakimoto Chain Co. 2002-05-28 |