The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Straight Or Finned Ventr Cath (w/radio Dots).
| Device ID | K960159 |
| 510k Number | K960159 |
| Device Name: | CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) |
| 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 | 1996-01-11 |
| Decision Date | 1996-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830056229 | K960159 | 000 |
| 00382830055604 | K960159 | 000 |
| 10381780035688 | K960159 | 000 |