HEMOBLAST Bellows
FDA premarket approval P170012 · decided 2017-12-15
Approval details
- PMA number
- P170012
- Trade name
- HEMOBLAST Bellows
- Generic name
- Absorbable collagen hemostatic agent with thrombin
- Applicant
- Dilon Technologies, Inc.
- Date received
- 2017-03-30
- Decision date
- 2017-12-15
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- PMX
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Newport News, VA
- Statement
- Approval of the Hemoblast Bellows. This device is indicated for surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DILON 6800 ACELLA (ACELLA) (K110384) | Dilon Technologies, Inc. | 2011-05-03 |
| DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5 (K984466) | Dilon Technologies, Inc. | 1999-03-16 |