V-CATH PERCUTANEOUS INTRODUCER KIT— 510(k) K951384
Substantially EquivalentHdc Corp.
FDA 510(k) clearance K951384 for V-CATH PERCUTANEOUS INTRODUCER KIT, Substantially Equivalent on 1995-06-23. Applicant: Hdc Corp.. Device class: 2.
Clearance details
- Applicant
- Hdc Corp.
- Product code
- Code KZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.6920
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code KZH
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
- K032404 — SELDINGER SAFETY NEEDLE INTRODUCER
- 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
Adverse events under product code KZH
product code KZH- Other
- 1
- Total
- 1
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.