FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
K Number: K896438
·
Decision Apr 10, 1990
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
102
Applicant Total
20
Review Days
152
Basic Information
- Device Name
- UPSIZING LEAD ADAPTERS 5.0MM PEEL-AWAY ADAPTER
- K Number
- K896438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3620
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- TELECTRONICS PACING SYSTEMS, INC.
- Date Received
- November 9, 1989
- Decision Date
- April 10, 1990
- Product Code
- DTD
- 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 |
|---|---|---|---|
| DTD | Pacemaker Lead Adaptor | FDA class 2 | Cardiovascular |
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Other Clearances by TELECTRONICS PACING SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K961118 | MAXIM PF MODELS 033-581/033-590 | Jul 15, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K943657 | STERILIZATION | Jun 24, 1996 | Substantially Equivalent - Subject to Tracking Reg. |
| K934899 | BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM | May 12, 1994 | Substantially Equivalent |
| K926340 | NEW LEAD INTRODUCER KITS, VARIOUS MODELS | May 27, 1993 | Substantially Equivalent |
| K914489 | NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING | Aug 17, 1992 | Substantially Equivalent |
| K913919 | UNIVERSAL TERMINAL CAP, 3.2MM | Dec 31, 1991 | Substantially Equivalent |
| K912773 | UNIPOLAR UPSIZING ADAPTOR | Oct 23, 1991 | Substantially Equivalent |
| K911273 | 100 CM PERMANENT PACING LEAD MODELS | Aug 28, 1991 | Substantially Equivalent |
| K910112 | BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR | Feb 25, 1991 | Substantially Equivalent |
| K903186 | OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE | Jan 18, 1991 | Substantially Equivalent |