LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE— 510(k) K870582
Substantially EquivalentStrato Medical Corp.
FDA 510(k) clearance K870582 for LIFEPORT(R) 7 INCH CONTINUOUS INFUSION W/Y-SITE, Substantially Equivalent on 1987-04-23. Applicant: Strato Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Strato Medical Corp.
- 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
- Beverly, MA, US
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More clearances from Strato Medical Corp.
view all- K945956 — STRATO MEDICAL INFUSE-A-CATH TRIPLE LUMEN SILICONE CATHETER SYSTEMS
- K946250 — STRATO MEDICAL INFUSE-A-CATH, TRIPLE LUMEN POLYURETHANE, CENTRAL VNOUS CATHETER SYSTEMS
- K942848 — STRATO MEDICAL LIFEPORT LPS 7515
- K934518 — STRATO MEDICAL INFUSE-A-PORT/INFUSE-A-KIT PERIPORT PERIPHERAL ACCESS SYSTEM
- K932509 — STRATO MEDICAL INFUSE-A-PORT/SNAP-LOCK MACROPRORT
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.