The following data is part of a premarket notification filed by Atrium Medical Corp. with the FDA for Express And Oasis Chest Drain.
| Device ID | K043140 |
| 510k Number | K043140 |
| Device Name: | EXPRESS AND OASIS CHEST DRAIN |
| Classification | Apparatus, Autotransfusion |
| Applicant | ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Contact | Joseph P De Paolo |
| Correspondent | Joseph P De Paolo ATRIUM MEDICAL CORP. 5 WENTWORTH DR. Hudson, NH 03051 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2004-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650862115219 | K043140 | 000 |
| 20650862110030 | K043140 | 000 |
| 20650862110054 | K043140 | 000 |
| 20650862110092 | K043140 | 000 |
| 20650862111013 | K043140 | 000 |
| 20650862111020 | K043140 | 000 |
| 20650862112010 | K043140 | 000 |
| 20650862113017 | K043140 | 000 |
| 20650862114014 | K043140 | 000 |
| 20650862115134 | K043140 | 000 |
| 20650862115141 | K043140 | 000 |
| 20650862115158 | K043140 | 000 |
| 20650862115165 | K043140 | 000 |
| 20650862110016 | K043140 | 000 |