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

Valve, Prosthesis

21 CFR 890.3420 / Physical Medicine
FDA source (opens on fda.gov)

ISP is the FDA product code for Valve, Prosthesis, a class I device type, regulated under 21 CFR 890.3420. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
ISP
Device name
Valve, Prosthesis
Regulation
21 CFR 890.3420
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code ISP

By decision year
1 clearance under product code ISP with a decision year between 1984 and 1984, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ISP by decision year
YearClearances
19841

Applicants with the most clearances

Product code ISP
Applicants holding the most 510(k) clearances under product code ISP
ApplicantClearances
Erich Jaeger, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order