The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Gt Leggiero.
| Device ID | K981359 |
| 510k Number | K981359 |
| Device Name: | GT LEGGIERO |
| Classification | Catheter, Percutaneous |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-14 |
| Decision Date | 1999-01-27 |
| Summary: | summary |