SPECTRA GUIDEWIRE INTRODUCER NEEDLE— 510(k) K082580
Substantially EquivalentSpectra Medical Devices, Inc.
FDA 510(k) clearance K082580 for SPECTRA GUIDEWIRE INTRODUCER NEEDLE, Substantially Equivalent on 2008-12-08. Applicant: Spectra Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectra Medical Devices, Inc.
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, MA, US
Recent devices under product code DYB
view allMore clearances from Spectra Medical Devices, Inc.
view all- K151069 — SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle
- K103740 — SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
- K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
- K082674 — SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
- K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L
Adverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.