FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
K Number: K964001
·
Decision Apr 17, 1998
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
26
Review Days
557
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Basic Information
- Device Name
- SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
- K Number
- K964001
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Med Institute, Inc.
- Date Received
- October 7, 1996
- Decision Date
- April 17, 1998
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
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ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
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FDA Class 2
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UltraDrape UGPIV Barrier and Securement (34-15)
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Other Clearances by Med Institute, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990034 | WILSON-COOK COLONIC Z-STENT | Apr 17, 2000 | Substantially Equivalent |
| K982507 | MINI POLYURETHANE CATHETER | Sep 16, 1998 | Substantially Equivalent |
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | May 26, 1998 | Substantially Equivalent |
| K971140 | VITAL-PORT INFUSION PAL | Nov 17, 1997 | Substantially Equivalent |
| K970442 | TARGET VITAL-PORT VASCULAR ACCESS SYSTEM | Apr 30, 1997 | Substantially Equivalent |
| K945586 | FLEXIBLE DILATING SHEATH | Apr 4, 1997 | Substantially Equivalent |
| K960698 | NON-CORING NEEDLE | Apr 15, 1996 | Substantially Equivalent |
| K941228 | ENDOLUMINAL ACCESS TUBE | Sep 27, 1995 | Unknown |
| K951077 | VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM | Jul 31, 1995 | Substantially Equivalent |
| K951076 | VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM | Jun 13, 1995 | Substantially Equivalent |