Leiningeo Aortic Punch #310-395 & 397
FDA 510(k) K771625 · J. Jamner Surgical Instruments, Inc.
510(k) numberK771625
Submission
- Device name
- Leiningeo Aortic Punch #310-395 & 397
- Applicant
- J. Jamner Surgical Instruments, Inc.
Mchenry, IL, US - Received
- August 25, 1977
- Decision date
- September 12, 1977
- 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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| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
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| K941565 | Jarit Recommended Sinus InstrumentsEOB · Traditional | 05/16/1994SE |
| K932456 | Jarit Surgical InstrumentsKNF · Traditional | 04/21/1994SE |
| K933728 | Jarit Surgical Instruments: Catalog 615-330, 615-331, 615-334, 615-335, 615-338, 615-339GEI · Traditional | 02/23/1994SE |
| K931928 | Jarit Surgical InstrumentsGCJ · Traditional | 11/10/1993SE |
| K931959 | Jarit Surgical InstrumentsGEI · Traditional | 10/05/1993SE |
| K931878 | Jarit Endoscopes, 600-600; 600-630; 600-650; 680GCJ · Traditional | 08/19/1993SE |
| K771624 | Cope Lung Forceps #305-218GEN · Traditional | 09/06/1977SE |
Questions and answers
When was Leiningeo Aortic Punch #310-395 & 397 cleared by the FDA?
Leiningeo Aortic Punch #310-395 & 397 (K771625) received a 510(k) decision of Substantially Equivalent on September 12, 1977, 18 days after the submission was received.
What is the product code of K771625?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.