← FDA Medical Device Classifications

Instruments, Surgical, Cardiovascular

DWS · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.4500

Classification

FDA Product Code
DWS
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 870.4500
Review panel
CV
Medical specialty
Cardiovascular
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Market data

Cleared 510(k) submissions
71
Registered establishments
314

Source

Authoritative
FDA Device Classification database
Machine
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