← Product Code [LOX](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX) · P850021

# AMER, ED. LABS. PTCA (P850021)

_Abbott Vascular, Inc. · LOX · May 30, 1986 · Cardiovascular · APWD_

**Canonical URL:** https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/P850021

## Device Facts

- **Applicant:** Abbott Vascular, Inc.
- **Product Code:** [LOX](/submissions/CV/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX.md)
- **Decision Date:** May 30, 1986
- **Decision:** APWD
- **Regulation:** 21 CFR 870.5100
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

Standard PTCA Catheter: A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion. Cutting/scoring PTCA Catheter: A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
*Cutting/scoring PTCA Catheter* —(1)*Identification.* A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
*Classification.* Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.

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**Source:** [https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/P850021](https://fda.innolitics.com/submissions/CARDIOVASCULAR/subpart-f%E2%80%94cardiovascular-therapeutic-devices/LOX/P850021)

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