UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR— 510(k) K013949
Substantially EquivalentChurchill Medical Systems, Inc.
FDA 510(k) clearance K013949 for UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR, Substantially Equivalent on 2002-03-27. 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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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Churchill Medical Systems, Inc.
view all- K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER
- K021395 — MODIFICATION TO 30 EXTENSION SET
- 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
- K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK
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.