UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET— 510(k) K000592
Substantially EquivalentMyco Medical Supplies, Inc.
FDA 510(k) clearance K000592 for UNOLOK PLUS INFUSION SET AND VAKU-8 PLUS BLOOD COLLECTION SET, Substantially Equivalent on 2001-04-12. Applicant: Myco Medical Supplies, Inc.. Device class: 2.
Clearance details
- Applicant
- Myco Medical Supplies, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cary, NC, US
Recent devices under product code FPA
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- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More 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
- K042504 — CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
- K990519 — PHOENIX EPIDURAL & SPINAL NEEDLES
Adverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.