The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Climber - Partially Coated Guide Wire For Endoscopic Use.
| Device ID | K971937 |
| 510k Number | K971937 |
| Device Name: | CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE |
| Classification | Endoscopic Guidewire, Gastroenterology-urology |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Kristine Wagner |
| Correspondent | Kristine Wagner TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | OCY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-08-15 |
| Summary: | summary |