FDA 510(k)

立石術周邊氣球擴張導管、立石術發生器和連接線、立石術連接線

K 號：K161384 · 2016-09-14

決定日期2016-09-14

產品代碼PPN

諮詢委員會履歷

決定相當於

器材摘要

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K161384. The device is classified under product code PPN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable?

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K161384.

When did Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable receive FDA 510(k) clearance?

Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable received FDA 510(k) clearance on 2016-09-14, under 510(k) number K161384.

Who is the listed applicant for Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable?

FDA 510(k) 記錄將 Shockwave Medical, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable?

The FDA product code for Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable is PPN.