MAXI LD PTA BALLOON CATHETER
K963000 · Cordis Corp. · LIT · Feb 20, 1997 · Cardiovascular
Device Facts
| Record ID | K963000 |
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| Device Name | MAXI LD PTA BALLOON CATHETER |
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| Applicant | Cordis Corp. |
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| Product Code | LIT · Cardiovascular |
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| Decision Date | Feb 20, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 870.1250 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended Use
The Maxi PTA catheter is intended to dilate lesions in large vessels.
Device Story
Over-the-wire balloon catheter; distal balloon; proximal hub; two radiopaque marker bands. Used by physicians in clinical settings for percutaneous transluminal angioplasty (PTA) to dilate stenotic lesions in large vessels. Device facilitates vessel patency by mechanical inflation of balloon at lesion site.
Clinical Evidence
Bench testing only. In vitro tests performed to ensure safety and effectiveness; all results met or exceeded specifications.
Technological Characteristics
Over-the-wire balloon catheter; radiopaque marker bands; materials passed biocompatibility testing.
Indications for Use
Indicated for the dilation of stenotic lesions in large vessels.
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Predicate Devices
- Cordis Opta 5 PTA Balloon Catheter
- Cordis Powerflex 5F PTA Balloon Catheter
- Cook Omega N.V. Balloon Dilatation Catheter
Related Devices
- K082646 — OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER · Usci Ireland · Nov 3, 2008
- K092286 — FOX SV PTA CATHETER · Abbott Vascular · Aug 27, 2009
- K093965 — ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS · C.R. Bard, Inc. · Mar 17, 2010
- K955886 — MEGA PTA BALLOON CATHETER · Cordis Corp. · Mar 11, 1996
- K123358 — PACIFIC PLUS · Medtronic Vascular · Jan 29, 2013
Submission Summary (Full Text)
{0}
07-00032
K963000
# Section 513(j) of the Federal Food, Drug and Cosmetic Act
## Summary of Safety and Effectiveness
July 26, 1996
FEB 20 1997
## I. General Provisions
Common or Usual name: PTA Balloon Catheter
Proprietary name: Cordis Maxi PTA Balloon Catheter
Name and Address of Applicant: Cordis Corporation
Miami Lakes Operation Center
14201 NW 60 Avenue
Miami Lakes, FL 33014
## II. Name of Predicate Devices
Cordis Opta 5 PTA Balloon Catheter
Cordis Powerflex 5F PTA Balloon Catheter
Cook Omega N.V. Balloon Dilatation Catheter
## III. Classification
PTA catheters are class II devices according to 21 CFR 870.1340.
## IV. Performance Standards
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
## V. Intended Use and Device Description
The Maxi PTA catheter is intended to dilate lesions in large vessels. The device is an over-the-wire balloon catheter, with a distal balloon and a proximal hub. The balloon is indicated by two radiopaque marker bands.
## VI. Biocompatibility
All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Maxi PTA Catheter.
## VII. In vitro Testing
{1}
00-00033
A series of in vitro tests were performed to assure that the introduction of the Maxi PTA catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications.
## VIII. Summary of Substantial Equivalence
The Maxi PTA catheter is designed for dilatation of stenotic lesions in large vessels. The Maxi PTA catheters have the same intended use, and several of the same materials, design characteristics and dimensions as the predicate devices.
