The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Telefelx Isis Hvt Tracheal Tube, Cuffed With Subglottic Secretion Suction Port; With Stylet.
| Device ID | K141939 |
| 510k Number | K141939 |
| Device Name: | TELEFELX ISIS HVT TRACHEAL TUBE, CUFFED WITH SUBGLOTTIC SECRETION SUCTION PORT; WITH STYLET |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | James A Cochie |
| Correspondent | James A Cochie Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-17 |
| Decision Date | 2014-11-24 |
| Summary: | summary |