The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Atw Marker Wire Steerable Guidewire.
| Device ID | K994358 |
| 510k Number | K994358 |
| Device Name: | ATW MARKER WIRE STEERABLE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Dennis S Griffin |
| Correspondent | Dennis S Griffin CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032056660 | K994358 | 000 |
| 20705032056578 | K994358 | 000 |
| 20705032056585 | K994358 | 000 |
| 20705032056592 | K994358 | 000 |
| 20705032056608 | K994358 | 000 |
| 20705032056615 | K994358 | 000 |
| 20705032056622 | K994358 | 000 |
| 20705032056639 | K994358 | 000 |
| 20705032056646 | K994358 | 000 |
| 20705032056653 | K994358 | 000 |
| 20705032056677 | K994358 | 000 |
| 20705032056684 | K994358 | 000 |
| 20705032056691 | K994358 | 000 |
| 20705032056561 | K994358 | 000 |