The following data is part of a premarket notification filed by Fresenius Medical Care Renal Therapies Group, Llc with the FDA for Stay•safe Catheter Extension Set With Safe-lock, 12 Inch, Stay•safe Catheter Extension Set With Luer-lock, 6 Inch, Stay•safe Catheter Extension Set With Luer-lock, 12 Inch, Stay•safe Catheter Extension Set With Luer-lock, 18 Inch, Stay•safe To Luer-l.
Device ID | K173593 |
510k Number | K173593 |
Device Name: | Stay•safe Catheter Extension Set With Safe-Lock, 12 Inch, Stay•safe Catheter Extension Set With Luer-Lock, 6 Inch, Stay•safe Catheter Extension Set With Luer-Lock, 12 Inch, Stay•safe Catheter Extension Set With Luer-Lock, 18 Inch, Stay•safe To Luer-L |
Classification | Set, Administration, For Peritoneal Dialysis, Disposable |
Applicant | Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
Contact | Denise Oppermann |
Correspondent | Denise Oppermann Fresenius Medical Care Renal Therapies Group, LLC 920 Winter Street Waltham, MA 02451 |
Product Code | KDJ |
CFR Regulation Number | 876.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-21 |
Decision Date | 2018-05-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10840861100771 | K173593 | 000 |
10840861100801 | K173593 | 000 |
10840861100795 | K173593 | 000 |
10840861100788 | K173593 | 000 |
10840861100764 | K173593 | 000 |