---
kind: "section"
citation: "21 C.F.R. § 870.5100"
title: "21"
number: "870.5100"
heading: "Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter."
url: "https://uscodex.org/cfr/21/870.5100"
---

# §870.5100. Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

- (a) **Standard PTCA Catheter—**
  - (1) **Identification.** 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.
  - (2) **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)](/cfr/21/870.1.md?p=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](/cfr/21/515.md) of the act is required before this device may be commercially distributed. See [§ 870.3](/cfr/21/870.3.md).

## Notes

### Amendments

[75 FR 54496, Sept. 8, 2010]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[75 FR 54496, Sept. 8, 2010]