The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Spectra Guidewire Introducer Needle.
| Device ID | K082580 |
| 510k Number | K082580 |
| Device Name: | SPECTRA GUIDEWIRE INTRODUCER NEEDLE |
| Classification | Introducer, Catheter |
| Applicant | SPECTRA MEDICAL DEVICES, INC. 260-H FORDHAM RD Wilmington, MA 01887 |
| Contact | Agustin Turriza |
| Correspondent | Agustin Turriza SPECTRA MEDICAL DEVICES, INC. 260-H FORDHAM RD Wilmington, MA 01887 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-05 |
| Decision Date | 2008-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801741086872 | K082580 | 000 |
| M661S010212753 | K082580 | 000 |
| M661S01318275 | K082580 | 000 |
| M661S01321275 | K082580 | 000 |
| 30849884004275 | K082580 | 000 |
| 30849884004282 | K082580 | 000 |
| 30849884004305 | K082580 | 000 |
| 38498840011752 | K082580 | 000 |
| 38498840011769 | K082580 | 000 |
| 20801741045138 | K082580 | 000 |
| M661S013182759 | K082580 | 000 |