FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEART-LIFT BALLOON POSITIONER
K Number: K982419
·
Decision Jan 13, 1999
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
3
Applicant Total
8
Review Days
184
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Basic Information
- Device Name
- HEART-LIFT BALLOON POSITIONER
- K Number
- K982419
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiothoracic Systems, Inc.
- Date Received
- July 13, 1998
- Decision Date
- January 13, 1999
- Product Code
- MWS
- 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 |
|---|---|---|---|
| MWS | Stabilizer, Heart | FDA class 1 | Cardiovascular |
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Other Clearances by Cardiothoracic Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010117 | GUIDANT AXIUS CORONARY SHUNT | Apr 4, 2001 | Substantially Equivalent |
| K983270 | VOYAGER QUAD CANNULA | Jul 28, 1999 | Substantially Equivalent |
| K983135 | BLOWER/MISTER | Nov 13, 1998 | Substantially Equivalent |
| K963965 | CTS MIDCAB STITCHER | Mar 17, 1998 | Substantially Equivalent |
| K970638 | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT | Oct 30, 1997 | Substantially Equivalent |
| K963503 | CTS MIDCAB CORONARY SHUNT | Apr 3, 1997 | Substantially Equivalent |
| K963930 | CTS MIDCAB/SVH BIPOLAR SCISSORS | Jan 16, 1997 | Substantially Equivalent |