FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBE, LEAD, AND CORD HOLDER NO. 102
K Number: K924568
·
Decision Nov 23, 1992
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
63
Applicant Total
5
Review Days
75
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Basic Information
- Device Name
- TUBE, LEAD, AND CORD HOLDER NO. 102
- K Number
- K924568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5210
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ansley Medical Products, Inc.
- Date Received
- September 9, 1992
- Decision Date
- November 23, 1992
- Product Code
- KMK
- 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 |
|---|---|---|---|
| KMK | Device, Intravascular Catheter Securement | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Ansley Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K932857 | ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC. | Sep 13, 1993 | Substantially Equivalent |
| K925290 | CATALOG NUMBER 111 (FACESHIELD) | Jul 23, 1993 | Substantially Equivalent |
| K924567 | FOLEY CATHETER TUBE HOLDER NO. 101 | Nov 23, 1992 | Substantially Equivalent |
| K924566 | RESTRAINT, PROTECTIVE N0. 103 | Nov 23, 1992 | Substantially Equivalent |