PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK— 510(k) K011336
Substantially EquivalentChurchill Medical Systems, Inc.
FDA 510(k) clearance K011336 for PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK, Substantially Equivalent on 2001-06-12. Applicant: Churchill Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Churchill Medical Systems, Inc.
- 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
- Dover, NH, US
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More clearances from Churchill Medical Systems, Inc.
view all- K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
- K021395 — MODIFICATION TO 30 EXTENSION SET
- K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR
- K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
- K013950 — VENTED VIAL ACCESS DEVICE
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.