← FDA Medical Device Classifications
Bag, Polymeric Mesh, Pacemaker
DSW · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.3650
Classification
- FDA Product Code
DSW- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 870.3650
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown