The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Endotracheal Tube, Accessory.
| Device ID | K862347 |
| 510k Number | K862347 |
| Device Name: | ENDOTRACHEAL TUBE, ACCESSORY |
| 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 | 1986-06-20 |
| Decision Date | 1986-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704398229 | K862347 | 000 |
| 34026704617945 | K862347 | 000 |
| 44026704617935 | K862347 | 000 |
| 44026704617928 | K862347 | 000 |
| 24026704588620 | K862347 | 000 |