The following data is part of a premarket notification filed by Intersurgical, Inc. with the FDA for Clear-therm 3 Hmef, Clear-therm 3 With Superset Catheter Mount,clear-therm With Flexible Catheter Mount,clear-guard 3 F3.
| Device ID | K024270 |
| 510k Number | K024270 |
| Device Name: | CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH FLEXIBLE CATHETER MOUNT,CLEAR-GUARD 3 F3 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Contact | Thomas R Gunerman |
| Correspondent | Thomas R Gunerman INTERSURGICAL, INC. 417 ELECTRONICS PKWY. Liverpool, NY 13088 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267084432 | K024270 | 000 |
| 05030267084418 | K024270 | 000 |
| 05030267038374 | K024270 | 000 |