510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K202916Substantially Equivalent

Balloon Guiding Catheter

Shanghai Heartcare Medical Technology Corporation Limited, Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202916 is the FDA 510(k) clearance record for Balloon Guiding Catheter, a class II device, cleared for Shanghai Heartcare Medical Technology Co., Ltd. on under FDA product code QJP (Catheter, Percutaneous, Neurovasculature). FDA's definition for product code QJP reads: "To provide vascular access to the neurovasculature for interventional or diagnostic procedures". FDA records list 3 510(k) clearances for Shanghai Heartcare Medical Technology Co., Ltd., from to . As of , FDA records show no recalls naming K202916.

Clearance record

Decision date
Received
(330 days to decision)
Product code
QJP Catheter, Percutaneous, Neurovasculature
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Shanghai Heartcare Medical Technology Co., Ltd. 590 Ruiqing Rd., Bldg. 4, Suite 201, E. Zhangjiang, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJP

Trailing 12 months
20 clearances under product code QJP in the twelve months to October 2026, April 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code QJP, trailing twelve months
MonthClearances
November 20250
December 20251
January 20263
February 20261
March 20260
April 20264
May 20262
June 20262
July 20263
August 20262
September 20262
October 20260