FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
K Number: K963248
·
Decision Feb 3, 1997
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
16
Review Days
168
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Basic Information
- Device Name
- FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
- K Number
- K963248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- J-Lloyd Medical, Inc.
- Date Received
- August 19, 1996
- Decision Date
- February 3, 1997
- Product Code
- DYG
- 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 |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | Cardiovascular |
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Other Clearances by J-Lloyd Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K973639 | ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC. | Apr 20, 1998 | Substantially Equivalent |
| K971504 | HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER | Apr 20, 1998 | Substantially Equivalent |
| K974335 | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | Feb 13, 1998 | Substantially Equivalent |
| K974336 | CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | Feb 13, 1998 | Substantially Equivalent |
| K950440 | DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD | Sep 15, 1995 | Substantially Equivalent |
| K940547 | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | Aug 11, 1994 | Substantially Equivalent |
| K935405 | ARTERIAL EMBOLECTOMY | Jul 25, 1994 | Substantially Equivalent |
| K935403 | WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD | May 12, 1994 | Substantially Equivalent |
| K935404 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | May 3, 1994 | Substantially Equivalent |
| K935402 | ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD | Apr 26, 1994 | Substantially Equivalent |