The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Teleflex Isis Hvt Tracheal Tube, Cuffed, With Subglottic Secretion Suction Port.
| Device ID | K091761 |
| 510k Number | K091761 |
| Device Name: | TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | William Heard |
| Correspondent | William Heard Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704588457 | K091761 | 000 |
| 44026704588327 | K091761 | 000 |
| 24026704588330 | K091761 | 000 |
| 44026704588341 | K091761 | 000 |
| 44026704588358 | K091761 | 000 |
| 24026704588361 | K091761 | 000 |
| 24026704588378 | K091761 | 000 |
| 44026704588389 | K091761 | 000 |
| 24026704588392 | K091761 | 000 |
| 44026704588402 | K091761 | 000 |
| 44026704588419 | K091761 | 000 |
| 24026704588422 | K091761 | 000 |
| 44026704588433 | K091761 | 000 |
| 44026704588440 | K091761 | 000 |
| 44026704400742 | K091761 | 000 |