510(k) · Cleared
ClearedHeartport Multifire Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heartport, Inc. · DSS Clip, Vascular
Cleared on Nov 15, 1996 after a 221-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 15, 1996
- Review
- 221 days
- Class
- Class II
- Product code
- DSS
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Pilling Weck - Hemoclip S15 Automatic Applier Named without a submission number | |
| * | — | U.S. Surgical - PREMIUM SURGICLIP Disposable Automatic Clip Applier Named without a submission number | |
| * | — | U.S. Surgical - ENDO CLIP Disposable Appliers Named without a submission number | |
| * | — | Ethicon - LIGACLIP Endoscopic Clip Applier Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DSS devicesDSS Clip, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DSS
FDA has decided no DSS device since 2007.
Median 510(k) review, days · DSS
Too few DSS 510(k)s in any year since 2007 to give a median.
Recalls per year · DSS
No recall names DSS since 2007.
Adverse event reports per year · DSS
2in 2025
MAUDE reports naming product code DSS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961333: Heartport Multifire Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961333
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026