The following data is part of a premarket notification filed by Advanced Biomedical Devices, Inc. with the FDA for Abd Varisoft Steerable Guide Wire And Abd Varisoft Guide Wire Extension.
| Device ID | K981936 |
| 510k Number | K981936 |
| Device Name: | ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION |
| Classification | Wire, Guide, Catheter |
| Applicant | ADVANCED BIOMEDICAL DEVICES, INC. 3 DUNDEE PARK Andover, MA 01810 |
| Contact | R. Edward Winters |
| Correspondent | R. Edward Winters ADVANCED BIOMEDICAL DEVICES, INC. 3 DUNDEE PARK Andover, MA 01810 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-02 |
| Decision Date | 2000-02-16 |