FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEUR TIP CAP, VLT CAP(TM)
K Number: K945454
·
Decision Apr 14, 1995
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
7
Review Days
158
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Basic Information
- Device Name
- LEUR TIP CAP, VLT CAP(TM)
- K Number
- K945454
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Martell Medical Products, Inc.
- Date Received
- November 7, 1994
- Decision Date
- April 14, 1995
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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Other Clearances by Martell Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944941 | PISTON SYRINGE | Dec 5, 1994 | Substantially Equivalent |
| K841810 | MARK5 ARTERIAL BLOOD GAS KIT | Jul 6, 1984 | Substantially Equivalent |
| K822786 | MDM ARTERIAL BLOOD GAS KIT | Oct 21, 1982 | Substantially Equivalent |
| K822760 | ARTERIAL LINE KIT | Sep 28, 1982 | Substantially Equivalent |
| K821096 | A-LINER | May 14, 1982 | Substantially Equivalent |
| K812560 | MDM ARTERIAL BLOOD GAS SYRINGE | Oct 9, 1981 | Substantially Equivalent |