GESCO PER-Q-CATH MIDLINE CATHETERS— 510(k) K971991
Substantially EquivalentBard Access Systems, Inc.
FDA 510(k) clearance K971991 for GESCO PER-Q-CATH MIDLINE CATHETERS, Substantially Equivalent on 1997-11-07. Applicant: Bard Access Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bard Access Systems, 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
- Salt Lake City, UT, US
Recent devices under product code FOZ
view allMore clearances from Bard Access Systems, Inc.
view all- K252478 — Vaccess CT Low-Profile Power-Injectable Implantable Port +2 more
- K251253 — PowerPort isp Implantable Port +3 more
- K241353 — PowerLoc Max Power Injectable Infusion Set; SafeStep Huber Needle Set
- K242328 — PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
- K240146 — BD Prevue II Peripheral Vascular Access System
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.