AORTIC PUMP
FDA 510(k) clearance K780567 · decided 1978-04-28
Clearance details
- K-number
- K780567
- Device name
- AORTIC PUMP
- Applicant
- ETHICON, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-04-06
- Decision date
- 1978-04-28
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- DWS
- Device class
- 1
- Regulation number
- 870.4500
- 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 |
|---|---|---|
| MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (K022238) | Medtronic Vascular | 2002-10-09 |
| OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (K964445) | Dlp, Inc. | 1997-01-30 |
| BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (K962771) | Pilling Weck, Inc. | 1996-11-19 |
| RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (K955689) | Contour Fabricators of Florida, Inc. | 1996-05-15 |
| G.E. STERILE ANGIOGRAPHIC TRAY (K960139) | GE Medical Systems | 1996-04-19 |
| G.E. STERILE CT BIOPSY TRAY (K960144) | GE Medical Systems | 1996-04-15 |
| G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (K960143) | GE Medical Systems | 1996-04-09 |
| REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (K934727) | Cardiac Pacemakers, Inc. | 1994-01-10 |
| HYCULT DIAMOND CORONARY BYPASS KNIFE (K900379) | St. Jude Medical, Inc. | 1990-03-19 |
| INSULATION PAD (K896307) | Bio-Vascular, Inc. | 1990-01-19 |
| MODEL 6888 LEAD TUNNELER (K894738) | Cardiac Pacemakers, Inc. | 1989-09-13 |
| NEWCHILL(TM) CARDIAC INSULATOR (K892804) | Acacia Laboratories, Inc. | 1989-07-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ETHIZIA (P240035) | ETHICON, Inc. | 2025-12-15 |
| INTERCEED Absorbable Adhesion Barrier (P880047/S068) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S127) | ETHICON, Inc. | 2025-12-12 |
| SURGICEL® Absorbable Hemostats (N12159/S122) | ETHICON, Inc. | 2025-11-04 |
| SURGICEL ORIGINAL 2INX14IN (5.1CMX35.6CM); SURGICEL ORIGINAL 4INX8IN (10.2CMX20.3CM); SURGICEL ORIGINAL 2INX3IN(5.1CMX7. (N12159/S126) | ETHICON, Inc. | 2025-10-09 |
| GYNECARE INTERCEED 3INX4IN(7.6CMX10.2CM); GYNECARE INTERCEED 5INX6IN(12.7CMX15.2CM); GYNECARE INTERCEED 3INX2IN(7.6CMX5. (P880047/S067) | ETHICON, Inc. | 2025-10-09 |
| SURGICEL® Absorbable Hemostats; SURGICEL® POWDER Absorbable Hemostatic Powder (N12159/S125) | ETHICON, Inc. | 2025-09-24 |
| GYNECARE INTERCEED Absorbable Adhesion Barrier (P880047/S066) | ETHICON, Inc. | 2025-09-24 |