FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATHETERIZATION TRAY & KIT
K Number: K780259
·
Decision Apr 18, 1978
Classifications
1
FEI Numbers
214
Registration Numbers
214
Same Product Code
28
Applicant Total
27
Review Days
62
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Basic Information
- Device Name
- CATHETERIZATION TRAY & KIT
- K Number
- K780259
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Argon Medical Corp.
- Date Received
- February 15, 1978
- Decision Date
- April 18, 1978
- Product Code
- KGZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KGZ | Accessories, Catheter | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGZ), ordered by most recent decision date.
AART SILICONE TUBING
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BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING
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FDA Class 1
·General, Plastic Surgery
WOUND DRAINAGE HOLDER
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DURALASTIC SILICONE TUBING
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NAVARRE PERCUTANEOUS ACCESS SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PALESTRANT IRRIGATION AND DRAINAGE SET
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Argon Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K904994 | CLOSED SYSTEM FLUSH SET | Jan 15, 1991 | Substantially Equivalent |
| K895511 | CATHETER BALLOON DILATOR PRESSURE GAUGE | Feb 28, 1990 | Substantially Equivalent |
| K894157 | OBTURATOR | Sep 28, 1989 | Substantially Equivalent |
| K891022 | INTRODUCER FOR PTCA GUIDING CATHETERS | May 19, 1989 | Substantially Equivalent |
| K884375 | TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER | Jan 11, 1989 | Substantially Equivalent |
| K882221 | OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE | Aug 12, 1988 | Substantially Equivalent |
| K871297 | KADIR HI-TORQUE GUIDE WIRE | Apr 10, 1987 | Substantially Equivalent |
| K853312 | ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES | Sep 12, 1985 | Substantially Equivalent |
| K852880 | PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET) | Aug 29, 1985 | Substantially Equivalent |
| K844555 | PATHFINDER CARDIOVASCULAR CATHETER | Mar 27, 1985 | Substantially Equivalent |