FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
IV START KIT
K Number: K935684
·
Decision Jun 10, 1994
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
29
Applicant Total
23
Review Days
193
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Basic Information
- Device Name
- IV START KIT
- K Number
- K935684
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Cush Medical Products
- Date Received
- November 29, 1993
- Decision Date
- June 10, 1994
- Product Code
- LRS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRS | I.V. Start Kit | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRS), ordered by most recent decision date.
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EMS I.V. START KIT
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B. BRAUN IV START KITS
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PERSONAL HEARING SYSTEM
FDA 510(k)
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Other Clearances by Cush Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K943424 | CUSH ISLAND DRESSING | Oct 3, 1994 | Substantially Equivalent for Some Indications |
| K940518 | C-SECTION TRAY | Aug 18, 1994 | Unknown |
| K941349 | DENTAL TRAY | Jul 26, 1994 | Substantially Equivalent for Some Indications |
| K941645 | BIOPSY TRAY | Jul 14, 1994 | Unknown |
| K940239 | EYE TRAY | Jun 28, 1994 | Unknown |
| K941455 | STERILE GAUZE PRODUCT LINE | May 20, 1994 | Unknown |
| K941522 | STERILE X-RAY DETECTABLE GAUZE SPONGES | May 12, 1994 | Substantially Equivalent |
| K941344 | LAP SPONGE PRODUCT LINE | May 12, 1994 | Substantially Equivalent |
| K935697 | CIRCUMCISION TRAY | May 2, 1994 | Unknown |
| K936120 | LABOR AND DELIVERY TRAY | Mar 30, 1994 | Unknown |