Pti Heart-Lift(Tm) Cardiac Support Sling (Sterile)
FDA 510(k) K881717 · Buckman Co., Inc.
510(k) numberK881717
Submission
- Device name
- Pti Heart-Lift(Tm) Cardiac Support Sling (Sterile)
- Applicant
- Buckman Co., Inc.
Martinez, CA, US - Received
- April 21, 1988
- Decision date
- July 5, 1988
- 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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| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
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| 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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Questions and answers
When was Pti Heart-Lift(Tm) Cardiac Support Sling (Sterile) cleared by the FDA?
Pti Heart-Lift(Tm) Cardiac Support Sling (Sterile) (K881717) received a 510(k) decision of Substantially Equivalent on July 5, 1988, 75 days after the submission was received.
What is the product code of K881717?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.