The following data is part of a premarket notification filed by Rex Medical with the FDA for Ultrastream Chronic Hemodialysis Catheter.
| Device ID | K102043 |
| 510k Number | K102043 |
| Device Name: | ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER |
| Classification | Catheter, Hemodialysis, Implanted |
| Applicant | REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein- Falk |
| Correspondent | Susan D Goldstein- Falk REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | MSD |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-20 |
| Decision Date | 2010-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886333222862 | K102043 | 000 |
| 10886333222732 | K102043 | 000 |
| 10886333222749 | K102043 | 000 |
| 10886333222756 | K102043 | 000 |
| 10886333222763 | K102043 | 000 |
| 10886333222770 | K102043 | 000 |
| 10886333222787 | K102043 | 000 |
| 10886333222794 | K102043 | 000 |
| 10886333222800 | K102043 | 000 |
| 10886333222817 | K102043 | 000 |
| 10886333222824 | K102043 | 000 |
| 10886333222831 | K102043 | 000 |
| 10886333222848 | K102043 | 000 |
| 10886333222855 | K102043 | 000 |
| 10886333222725 | K102043 | 000 |