FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WINGED NON-CORING NEEDLE SET
K Number: K884212
·
Decision Oct 17, 1988
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
17
Review Days
11
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Basic Information
- Device Name
- WINGED NON-CORING NEEDLE SET
- K Number
- K884212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Marquette Medical, Inc.
- Date Received
- October 6, 1988
- Decision Date
- October 17, 1988
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K952976 | PLASTIC BLUNT CANNULA | Sep 15, 1995 | Substantially Equivalent |
| K920537 | SUBCUTANEOUS INFUSION SET | Oct 13, 1992 | 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 |