510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221414Substantially Equivalent

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter

Silk Road Medical, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221414 is the FDA 510(k) clearance record for ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter, a class II device, cleared for Silk Road Medical, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 6 510(k) clearances for Silk Road Medical, Inc., from to . As of , FDA records show no recalls naming K221414.

Clearance record

Decision date
Received
(109 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Silk Road Medical, Inc. 1213 Innsbruck Dr., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260