FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
UNIVERSAL TERMINAL CAP, 3.2MM
K Number: K913919
·
Decision Dec 31, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
20
Review Days
119
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Basic Information
- Device Name
- UNIVERSAL TERMINAL CAP, 3.2MM
- K Number
- K913919
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3710
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Telectronics Pacing Systems, Inc.
- Date Received
- September 3, 1991
- Decision Date
- December 31, 1991
- Product Code
- KFJ
- 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 |
|---|---|---|---|
| KFJ | Materials, Repair Or Replacement, Pacemaker | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFJ), ordered by most recent decision date.
MEDTRONIC MODEL 5867-1A
FDA 510(k)
FDA Class 3
·Cardiovascular
IMPLANT AID SPLICING CRIMP & SLEEVE
FDA 510(k)
FDA Class 3
·Cardiovascular
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 |
| 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 |
| K904741 | LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES | Jan 8, 1991 | Substantially Equivalent |