FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER BALLOON DILATOR PRESSURE GAUGE
K Number: K895511
·
Decision Feb 28, 1990
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
56
Applicant Total
27
Review Days
169
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Basic Information
- Device Name
- CATHETER BALLOON DILATOR PRESSURE GAUGE
- K Number
- K895511
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Argon Medical Corp.
- Date Received
- September 12, 1989
- Decision Date
- February 28, 1990
- Product Code
- MAV
- 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 |
|---|---|---|---|
| MAV | Syringe, Balloon Inflation | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MAV), ordered by most recent decision date.
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
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Other Clearances by Argon Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K904994 | CLOSED SYSTEM FLUSH SET | Jan 15, 1991 | 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 |
| K842039 | ARGON DUAL LUMEN HEMODIALYSIS, CATHETER | Jan 29, 1985 | Substantially Equivalent |