SELDINGER SAFETY NEEDLE INTRODUCER— 510(k) K032404
Substantially EquivalentHdc Corp.
FDA 510(k) clearance K032404 for SELDINGER SAFETY NEEDLE INTRODUCER, Substantially Equivalent on 2003-09-10. Applicant: Hdc Corp.. Device class: 2.
Clearance details
- Applicant
- Hdc Corp.
- 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
- Special
- Location
- Milpitas, CA, US
Recent devices under product code DYB
view allMore clearances from Hdc Corp.
view all- K071875 — V-CATH POLY PICC
- K023342 — NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE MAPPING PROBE, NEURO-TRACE III NERVE BG
- K033853 — MODIFICATION TO V-CATH POLY PICC
- K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
- K022099 — SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
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.