Spectra Guidewire Introducer Needle
FDA 510(k) K082580 · Spectra Medical Devices, Inc.
510(k) numberK082580
Submission
- Device name
- Spectra Guidewire Introducer Needle
- Applicant
- Spectra Medical Devices, Inc.
Wilmington, MA, US - Received
- September 5, 2008
- Decision date
- December 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K082674 | Spectra-Glass Lor (Loss of Resistance Syringe, 5CC Metal L/S or L/L Tip, Spectra-Glass…FMF · Traditional | 11/28/2008SE |
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Questions and answers
When was Spectra Guidewire Introducer Needle cleared by the FDA?
Spectra Guidewire Introducer Needle (K082580) received a 510(k) decision of Substantially Equivalent on December 8, 2008, 94 days after the submission was received.
What is the product code of K082580?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.