FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEART CATHETERIZATION TRAY SET
K Number: K840022
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- HEART CATHETERIZATION TRAY SET
- K Number
- K840022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Medi-Plast Intl., Inc.
- Date Received
- January 5, 1984
- Decision Date
- February 4, 1984
- Product Code
- DRE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Medi-Plast Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954284 | MEDI-PLAST 2 PORT MANIFOLD (RIGHT ON) | Feb 12, 1996 | Substantially Equivalent |
| K873588 | 10CC CONTROL SYRINGE | Oct 23, 1987 | Substantially Equivalent |
| K863402 | MEDI-PLAST DISPOSABLE MANIFOLD | Oct 22, 1986 | Substantially Equivalent |
| K861785 | FLUOROSCOPE BAND BAG | Jun 13, 1986 | Substantially Equivalent |
| K851489 | ARTERIAL-VENOUS COMPRESSION DRESSING | Jun 11, 1985 | Substantially Equivalent |
| K842136 | STERILE PAN SET | Jul 6, 1984 | Substantially Equivalent |
| K840021 | OPERATING ROOM TRAY SET | Mar 15, 1984 | Substantially Equivalent |
| K811268 | BOTTLE-TO-BOTTLE | Jun 18, 1981 | Substantially Equivalent |
| K811234 | I.V. BOTTLE (RIDGID) | Jun 18, 1981 | Substantially Equivalent |
| K811233 | I.V. PLASTIC BAG | Jun 17, 1981 | Substantially Equivalent |