FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
K Number: K020544
·
Decision Mar 12, 2002
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
25
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Basic Information
- Device Name
- WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1900 SERIES; WING SAFE INFUSION SET 22 GA
- K Number
- K020544
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Churchill Medical Systems, Inc.
- Date Received
- February 15, 2002
- Decision Date
- March 12, 2002
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Churchill Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041038 | CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER | Dec 21, 2004 | Substantially Equivalent |
| K021395 | MODIFICATION TO 30 EXTENSION SET | May 13, 2002 | Substantially Equivalent |
| K013949 | UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR | Mar 27, 2002 | Substantially Equivalent |
| K013950 | VENTED VIAL ACCESS DEVICE | Jan 10, 2002 | Substantially Equivalent |
| K012157 | CHURCHILL MEDICAL SYSTEMS STOPCOCK | Sep 11, 2001 | Substantially Equivalent |
| K011888 | PRESSURE ACTIVATED CHECK VALVE | Sep 10, 2001 | Substantially Equivalent |
| K011336 | PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK | Jun 12, 2001 | Substantially Equivalent |
| K896333 | CMS IV FILTERS | Jan 11, 1990 | Substantially Equivalent |
| K894954 | .22 & 1.2 MICRON IV FILTERS | Nov 13, 1989 | Substantially Equivalent |
| K884370 | CMS IV EXTENSION SETS | Nov 7, 1988 | Substantially Equivalent |