ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
FDA 510(k) clearance K852641 · decided 1986-01-14
Clearance details
- K-number
- K852641
- Device name
- ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-20
- Decision date
- 1986-01-14
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- DXY
- Device class
- 3
- Regulation number
- 870.3610
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Sorin Biomedica
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S003) | Sorin Biomedica, Fiat, USA, Inc. | 1987-02-17 |
| AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S002) | Sorin Biomedica, Fiat, USA, Inc. | 1986-10-31 |
| AB-CORE K HEPATITIS B CORE ANTIGEN 125I (P850044/S001) | Sorin Biomedica, Fiat, USA, Inc. | 1986-08-26 |