510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NRYClass II

Catheter, Thrombus Retriever

21 CFR 870.1250 / Cardiovascular
FDA source (opens on fda.gov)

NRY is the FDA product code for Catheter, Thrombus Retriever, a class II device type, regulated under 21 CFR 870.1250. FDA's definition for this code reads: "The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be...". As of , FDA records hold 114 510(k) clearances under this code, the most recent dated , and 26 recalls.

Classification record

Product code
NRY
Device name
Catheter, Thrombus Retriever
FDA definition
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
115
Ingested recalls
27

Clearances, product code NRY

By decision year
115 clearances under product code NRY with a decision year between 2004 and 2026, 2025 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code NRY by decision year
YearClearances
20041
20061
20075
20082
20092
20101
20112
20124
20144
20156
20165
20173
201811
20197
20206
20219
20223
20238
20248
202515
202612

Applicants with the most clearances

Product code NRY
Applicants holding the most 510(k) clearances under product code NRY
ApplicantClearances
Penumbra Inc.25
Concentric Medical, Inc.16
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular11
Alembic LLC7
Imperative Care Inc.7
Cerenovus, Inc.6
Perfuze6
Neuravi Limited5
Rapid Medical Inc.5
Stryker Corp.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 50 companies shown, in name order