FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBCUTANEOUS INFUSION SET
K Number: K920537
·
Decision Oct 13, 1992
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
17
Review Days
251
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Basic Information
- Device Name
- SUBCUTANEOUS INFUSION SET
- K Number
- K920537
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Marquette Medical, Inc.
- Date Received
- February 5, 1992
- Decision Date
- October 13, 1992
- 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 Marquette Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K021471 | MARQUETTE HUBER TRAP SAFETY INFUSION SET | Sep 8, 2003 | Substantially Equivalent |
| K953008 | INFANT FEEDING TUBE | Jan 11, 1996 | Substantially Equivalent |
| K952976 | PLASTIC BLUNT CANNULA | Sep 15, 1995 | Substantially Equivalent |
| K905218 | 4 LOW VOLUME IV EXTENSION SET WITH SLIDE CLAMP | Jun 4, 1991 | Substantially Equivalent |
| K905219 | 4' LOW VOLUME IV EXTENSION SET | Jun 4, 1991 | Substantially Equivalent |
| K905374 | IV EXTENSION SETS WITH .22 MICRON FILTER | May 31, 1991 | Substantially Equivalent |
| K901089 | LOW VOLUME TRIFURCATED IV EXTENSION SET | Oct 4, 1990 | Substantially Equivalent |
| K901088 | LOW VOLUME BIFURCATED IV EXTENSION SET | Oct 4, 1990 | Substantially Equivalent |
| K900427 | IV TRIFURCATED EXTENSION SET | Feb 28, 1990 | Substantially Equivalent |
| K900426 | IV BIFURCATED EXTENSION SET | Feb 28, 1990 | Substantially Equivalent |