CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER— 510(k) K042504
Substantially EquivalentMyco Medical Supplies, Inc.
FDA 510(k) clearance K042504 for CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER, Substantially Equivalent on 2006-01-19. Applicant: Myco Medical Supplies, Inc.. Device class: 2.
Clearance details
- Applicant
- Myco Medical Supplies, Inc.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cary, NC, US
Recent devices under product code FOZ
view allMore clearances from Myco Medical Supplies, Inc.
view all- K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
- K173279 — RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
- K090426 — VAKU-8 BLOOD COLLECTION NEEDLES
- K000592 — UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET
- K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.