The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Kimvent Microcuff Subglottic Suctioning Endotracheal Tube.
| Device ID | K131254 |
| 510k Number | K131254 |
| Device Name: | KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Contact | Marcia Johnson |
| Correspondent | Marcia Johnson KIMBERLY-CLARK CORP. 1400 HOLCOMB BRIDGE RD. Roswell, GA 30076 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-02 |
| Decision Date | 2013-08-20 |
| Summary: | summary |