INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022— 510(k) K083851
Substantially EquivalentInviro Medical Devices, Inc.
FDA 510(k) clearance K083851 for INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022, Substantially Equivalent on 2009-05-15. Applicant: Inviro Medical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Inviro Medical Devices, Inc.
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lawrenceville, GA, US
Recent devices under product code LHI
view allMore clearances from Inviro Medical Devices, Inc.
view all- K101359 — INVIROSTRIPE LUER LOCK SYRINGES (1, 3, 10, 20, 30 AND 60 ML)
- K092413 — INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES
- K092430 — 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES
- K081436 — INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
- K071307 — INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
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.