The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics Lld Cs, Model 518-039.
| Device ID | K043401 |
| 510k Number | K043401 |
| Device Name: | SPECTRANETICS LLD CS, MODEL 518-039 |
| Classification | Stylet, Catheter |
| Applicant | SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Contact | Michael J Ryan |
| Correspondent | Michael J Ryan SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs, CO 80907 -5159 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-10 |
| Decision Date | 2005-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M204518039AB0 | K043401 | 000 |
| M204518021AA0 | K043401 | 000 |
| 00813132020743 | K043401 | 000 |
| M2045180391 | K043401 | 000 |
| M2045180270 | K043401 | 000 |
| M2045180240 | K043401 | 000 |
| M2045180230 | K043401 | 000 |
| M2045180220 | K043401 | 000 |
| M2045180210 | K043401 | 000 |
| M2045180201 | K043401 | 000 |
| M2045180191 | K043401 | 000 |
| 00813132020767 | K043401 | 000 |
| M204518022AA0 | K043401 | 000 |
| 00813132020781 | K043401 | 000 |
| M204518023AB0 | K043401 | 000 |
| M204518020AB0 | K043401 | 000 |
| M204518022AB0 | K043401 | 000 |
| M204518019AB0 | K043401 | 000 |
| M204518021AB0 | K043401 | 000 |
| M204518018AB0 | K043401 | 000 |
| 00813132020828 | K043401 | 000 |
| M204518027AA0 | K043401 | 000 |
| M204518024AA0 | K043401 | 000 |
| M204518023AA0 | K043401 | 000 |
| M2045180181 | K043401 | 000 |