FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOCKING STYLET 2
K Number: K970690
·
Decision May 20, 1997
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
34
Review Days
84
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Basic Information
- Device Name
- LOCKING STYLET 2
- K Number
- K970690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Pacemaker Corp.
- Date Received
- February 25, 1997
- Decision Date
- May 20, 1997
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Cook Pacemaker Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K961992 | NEEDLE'S EYE SNARE | Dec 27, 1996 | Substantially Equivalent |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Sep 29, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD | Sep 11, 1992 | Unknown |
| K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | Oct 16, 1991 | Substantially Equivalent |
| K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) | Oct 8, 1986 | Substantially Equivalent |
| K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS | May 9, 1986 | Substantially Equivalent |
| K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. | Feb 24, 1986 | Substantially Equivalent |
| K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. | Feb 24, 1986 | Substantially Equivalent |
| K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY | Dec 19, 1985 | Substantially Equivalent |
| K854132 | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS | Dec 3, 1985 | Substantially Equivalent |