The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Spiral-flex.
| Device ID | K860105 | 
| 510k Number | K860105 | 
| Device Name: | SPIRAL-FLEX | 
| Classification | Tube, Tracheal (w/wo Connector) | 
| Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 | 
| Contact | Steen, Ph.d. | 
| Correspondent | Steen, Ph.d. SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 | 
| Product Code | BTR | 
| CFR Regulation Number | 868.5730 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1986-01-13 | 
| Decision Date | 1986-03-04 | 
| Device Identifier | submissionNumber | Supplement | 
|---|---|---|
| 44026704617164 | K860105 | 000 | 
| 34026704759942 | K860105 | 000 | 
| 34026704759959 | K860105 | 000 | 
| 24026704759969 | K860105 | 000 | 
| 24026704759976 | K860105 | 000 | 
| 24026704397451 | K860105 | 000 | 
| 24026704397468 | K860105 | 000 | 
| 24026704397475 | K860105 | 000 | 
| 44026704397486 | K860105 | 000 | 
| 24026704397499 | K860105 | 000 | 
| 44026704617126 | K860105 | 000 | 
| 44026704617133 | K860105 | 000 | 
| 44026704617140 | K860105 | 000 | 
| 34026704617150 | K860105 | 000 | 
| 24026704759938 | K860105 | 000 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SPIRAL-FLEX  73768215  1559680 Live/Registered | SHERIDAN CATHETER CORP. 1988-12-02 |