FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DISPOSABLE TEMPORARY PACING WIRE
K Number: K023174
·
Decision Jun 11, 2003
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
16
Review Days
261
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Basic Information
- Device Name
- DISPOSABLE TEMPORARY PACING WIRE
- K Number
- K023174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- River Medical, Inc.
- Date Received
- September 23, 2002
- Decision Date
- June 11, 2003
- 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 River Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944351 | SMARTDOSE IV PREFILLED INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K944352 | SMARTDOSE III INFUSION CONTAINER | Nov 15, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K945298 | SMARTFLOW I ADMINISTRATION SET | Jun 14, 1995 | Substantially Equivalent |
| K943692 | SMART DOSE(TM) | Apr 28, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K932895 | RIVER PUMP | Mar 31, 1994 | Substantially Equivalent |
| K933335 | RIVER VIAL ADAPTER | Mar 1, 1994 | Substantially Equivalent |
| K915120 | TEF/PLATINUM PISTON | Dec 27, 1991 | Substantially Equivalent |
| K915121 | TEF/WIRE PISTON | Dec 23, 1991 | Substantially Equivalent |
| K913287 | H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET | Dec 18, 1991 | Substantially Equivalent |
| K913285 | PTFE PISTON | Dec 18, 1991 | Substantially Equivalent |