The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for 0.016 Guide Wire For Neurological Endoscope.
| Device ID | K913074 |
| 510k Number | K913074 |
| Device Name: | 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE |
| Classification | Wire, Guide, Catheter |
| Applicant | TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Contact | Alan B Hershman |
| Correspondent | Alan B Hershman TERUMO MEDICAL CORP. P.O. BOX 605 Elkton, MD 21912 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-11 |
| Decision Date | 1991-11-05 |