FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
K Number: K971775
·
Decision Dec 29, 1997
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
26
Review Days
230
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Basic Information
- Device Name
- INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610
- K Number
- K971775
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiac Control Systems, Inc.
- Date Received
- May 13, 1997
- Decision Date
- December 29, 1997
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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Other Clearances by Cardiac Control Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | May 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | May 3, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | May 14, 1993 | Substantially Equivalent |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | May 16, 1991 | Substantially Equivalent |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | Jan 3, 1991 | Substantially Equivalent |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | Sep 26, 1989 | Substantially Equivalent |
| K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | Oct 17, 1988 | Substantially Equivalent |
| K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD | Oct 14, 1988 | Substantially Equivalent |
| K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP | Oct 6, 1988 | Substantially Equivalent |
| K883016 | POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP | Sep 16, 1988 | Substantially Equivalent |