AMSURE PVC INTERMITTENT CATHETER— 510(k) K091306
Substantially EquivalentAmsino International, Inc.
FDA 510(k) clearance K091306 for AMSURE PVC INTERMITTENT CATHETER, Substantially Equivalent on 2009-08-21. Applicant: Amsino International, Inc.. Device class: 2.
Clearance details
- Applicant
- Amsino International, Inc.
- Product code
- Code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pomona, CA, US
Recent devices under product code EZD
view allMore clearances from Amsino International, Inc.
view all- 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)
- K220230 — AMSure Enteral Feeding Pump
- K220267 — AMSafe NeuFlo Needleless Connector
- K213522 — AMSafe Pre-Filled Normal Saline Flush Syringe
- K200051 — PUGGLE Enteral Feeding Pump and Feeding Set
Adverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
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.