510(k) · Cleared
ClearedV. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carefusion 2200, Inc. · DXC Clamp, Vascular
Cleared on Mar 4, 2021 as substantially equivalent to K974769 (Allegiance Healthcare Corp., 1998) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 4, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- DXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951413 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK951413 Fogarty-Hydragrip Surgical ClampsBaxter Healthcare Corp · 1995
- 2 generations backK974769 Cosgrove ClampAllegiance Healthcare Corp. · 1998
- 1 generation backK991589 Flexible Vascular Clamp, Version 2Allegiance Healthcare Corp. · 1999
- This deviceK210324 V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061…Carefusion 2200, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951413 | Fogarty-Hydragrip Surgical Clamps | Baxter Healthcare Corp | 1995 | — |
| −2 | K974769 | Cosgrove Clamp | Allegiance Healthcare Corp. | 1998 | — |
| −1 | K991589 | Flexible Vascular Clamp, Version 2 | Allegiance Healthcare Corp. | 1999 | — |
| 0 (this device) | K210324 | V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161… | Carefusion 2200, Inc. | 2021 | — |
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 DXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXC device
- #1 K262086 PreludeSYNC™ Radial Compression Devicescore 13.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K974769 | Cosgrove ClampSummary page 4…ss II per 21CFR 870.4450, Product code DXC Product Code(s) CV1033, CV1061, CV1133, CV1161, CV1186 Legally marketed device(s) to Cosgrove Flex Clamp – K974769 which equivalence is claimed Cosgrove Flex Clamp Quick-Bend™ - K991589 Reason for 510(k) submission Design and labeling m… | 1998 |
| * | K991589 | Flexible Vascular Clamp, Version 2Summary page 4…CV1033, CV1061, CV1133, CV1161, CV1186 Legally marketed device(s) to Cosgrove Flex Clamp – K974769 which equivalence is claimed Cosgrove Flex Clamp Quick-Bend™ - K991589 Reason for 510(k) submission Design and labeling modifications Device description Each V. Mueller Cosgrove™ Fl… | 1999 |
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.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K974769.
How does its category compare?
All DXC devicesDXC Clamp, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DXC
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXC
215in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXC
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXC
442in 2025
MAUDE reports naming product code DXC, 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 | 10 | 52 | 0 | 298 |
| 2008 | 3 | 29 | 2 | 302 |
| 2009 | 4 | 83 | 2 | 539 |
| 2010 | 2 | — | 1 | 600 |
| 2011 | 6 | 51 | 3 | 691 |
| 2012 | 5 | 73 | 0 | 548 |
| 2013 | 14 | 89 | 0 | 920 |
| 2014 | 4 | 157 | 1 | 494 |
| 2015 | 5 | 71 | 0 | 374 |
| 2016 | 3 | 91 | 0 | 494 |
| 2017 | 3 | 90 | 0 | 416 |
| 2018 | 2 | — | 0 | 391 |
| 2019 | 2 | — | 0 | 393 |
| 2020 | 3 | 209 | 0 | 404 |
| 2021 | 6 | 37 | 0 | 371 |
| 2022 | 1 | — | 1 | 273 |
| 2023 | 4 | 215 | 2 | 674 |
| 2024 | 1 | — | 0 | 375 |
| 2025 | 2 | — | 0 | 442 |
| 2026 | 4 | 125 | 0 | — |
What is it indicated for?
The V. Mueller Cosgrove™ Flex Clamps are indicated to be used to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210324 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210324: V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210324
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026