KSDClass I
Device, Heat-Sealing
21 CFR 864.9750 / Hematology
KSD is the FDA product code for Device, Heat-Sealing, a class I device type, regulated under 21 CFR 864.9750. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- KSD
- Device name
- Device, Heat-Sealing
- Regulation
- 21 CFR 864.9750
- Device class
- Class I
- Review panel
- Hematology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code KSD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
Applicants with the most clearances
Product code KSD| Applicant | Clearances |
|---|---|
| North American Biologicals, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
