Hycult Diamond Coronary Bypass Knife
FDA 510(k) K900379 · St. Jude Medical, Inc.
510(k) numberK900379
Submission
- Device name
- Hycult Diamond Coronary Bypass Knife
- Applicant
- St. Jude Medical, Inc.
St. Paul, MN, US - Received
- January 26, 1990
- Decision date
- March 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 09/13/1989SE |
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Questions and answers
When was Hycult Diamond Coronary Bypass Knife cleared by the FDA?
Hycult Diamond Coronary Bypass Knife (K900379) received a 510(k) decision of Substantially Equivalent on March 19, 1990, 52 days after the submission was received.
What is the product code of K900379?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.