FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBCUTANEOUS INFUSION SET
K Number: K932637
·
Decision Jan 7, 1994
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
19
Review Days
219
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Basic Information
- Device Name
- SUBCUTANEOUS INFUSION SET
- K Number
- K932637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Douglas Medical Products Corp.
- Date Received
- June 2, 1993
- Decision Date
- January 7, 1994
- 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 Douglas Medical Products Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961155 | SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 | Jun 18, 1996 | Substantially Equivalent |
| K954428 | SOLOPICC 24 (60CM) 20GA CATHETER | Mar 28, 1996 | Substantially Equivalent |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | Feb 16, 1995 | Substantially Equivalent |
| K942101 | 4-LEAD IRRIGATION SET | Sep 30, 1994 | Substantially Equivalent |
| K941453 | CHECK VALVE SOLUTION SET | Aug 16, 1994 | Substantially Equivalent |
| K930854 | SOLUTION SET WITH .2 MICRON FILTER | Jan 14, 1994 | Substantially Equivalent |
| K931659 | 3 LEAD CONNECTOR | Jan 7, 1994 | Substantially Equivalent |
| K931658 | IN-LINE BURETTE SET | Dec 21, 1993 | Substantially Equivalent |
| K932638 | HUBER NEEDLE INFUSION SET | Dec 14, 1993 | Substantially Equivalent |
| K932641 | EMPTY MIXING CONTAINER | Nov 10, 1993 | Substantially Equivalent |