DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)
FDA 510(k) clearance K890432 · decided 1989-04-13
Clearance details
- K-number
- K890432
- Device name
- DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)
- Applicant
- Deknatel, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-27
- Decision date
- 1989-04-13
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- DWS
- Device class
- 1
- Regulation number
- 870.4500
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose-Heredia, CR
- Third-party review
- No
- Expedited review
- No
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| 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 |
|---|---|---|
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S006) | Deknatel, Inc. | 1989-06-16 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S007) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S011) | Deknatel, Inc. | 1989-06-16 |
| DEKLENE(TM) (P810028/S010) | Deknatel, Inc. | 1989-02-02 |
| NONABSORBABLE SURG. SUTURES, NYLON (N85060/S005) | Deknatel, Inc. | 1989-01-31 |
| DEKLENE(TM) (P810028/S008) | Deknatel, Inc. | 1989-01-31 |
| CHROMIC GUT SUTURE (N84381/S007) | Deknatel, Inc. | 1989-01-31 |
| NONABSORBABLE SURG. SUTURES, BRAIDED SILK (N84348/S004) | Deknatel, Inc. | 1989-01-31 |