TUBING PACK, EXTRACORPOREAL, H-3000
FDA 510(k) clearance K770720 · decided 1977-08-04
Clearance details
- K-number
- K770720
- Device name
- TUBING PACK, EXTRACORPOREAL, H-3000
- Applicant
- William Harvey Life Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-18
- Decision date
- 1977-08-04
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- BYS
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Nautilus VF ECMO Oxygenator (K232767) | Mc3, Inc. | 2023-10-04 |
| Nautilus Smart ECMO Module (K191935) | Mc3 Incorporated | 2020-04-09 |
Recalls involving this device
No recalls on record reference this clearance.