The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Agento I.c. Silver-coated Endotracheal Tube.
| Device ID | K071365 |
| 510k Number | K071365 |
| Device Name: | AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Michelle R Gudith |
| Correspondent | Michelle R Gudith C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-05-15 |
| Decision Date | 2007-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801741067331 | K071365 | 000 |
| 10801741067324 | K071365 | 000 |
| 10801741067317 | K071365 | 000 |
| 10801741067300 | K071365 | 000 |
| 10801741067294 | K071365 | 000 |
| 10801741067287 | K071365 | 000 |
| 10801741067270 | K071365 | 000 |
| 10801741067263 | K071365 | 000 |