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 |