The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Sharp-ended Stylet; Blunt-ended Stylet; Cyst Puncture Catheter.
| Device ID | K955265 |
| 510k Number | K955265 |
| Device Name: | CORDIS SHARP-ENDED STYLET; BLUNT-ENDED STYLET; CYST PUNCTURE CATHETER |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Stephen M Enos |
| Correspondent | Stephen M Enos CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-14 |
| Decision Date | 1996-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780034285 | K955265 | 000 |