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

System, Catheter Or Guidewire, Steerable (Magnetic)

21 CFR 870.1290 / Cardiovascular
FDA source (opens on fda.gov)

NDQ is the FDA product code for System, Catheter Or Guidewire, Steerable (Magnetic), a class II device type, regulated under 21 CFR 870.1290. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NDQ
Device name
System, Catheter Or Guidewire, Steerable (Magnetic)
Regulation
21 CFR 870.1290
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
2
Ingested recalls
0

Clearances, product code NDQ

By decision year
2 clearances under product code NDQ with a decision year between 2005 and 2006, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NDQ by decision year
YearClearances
20051
20061

Applicants with the most clearances

Product code NDQ
Applicants holding the most 510(k) clearances under product code NDQ
ApplicantClearances
Stereotaxis Inc2

Companies listing this code with FDA

Companies whose registered establishments list this code