IVAC PC ANIFUSER— 510(k) K915063
Substantially EquivalentY
FDA 510(k) clearance K915063 for IVAC PC ANIFUSER, Substantially Equivalent on 1992-06-03. Applicant: Y. Device class: 2.
Clearance details
- Applicant
- Y
- Product code
- Code MEA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Recent devices under product code MEA
view all- K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump
- K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication +4 more
- K143612 — LifeCare PCA Infusion System
- K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0
- K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
More clearances from Y
view all- K955846 — MODEL 2082 TEMP PLUS III THERMOMETER/MODEL 2087 TEMP PLUS III WALL MOUNT THERMOMETER
- K960280 — IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
- K953225 — IVAC BALL VALCE ADMIN. SETS
- K934095 — IVAC VENTED SYRINGE ADAPTER ADMINISTRATION SETS
- K940897 — IVAC NEEDLELESS INFECTION VALVE ADMINISTRATION SET
Adverse events under product code MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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.