510(k) Report

510(k) · Cleared

Cleared

CPS Courier Guidewire

K073082510(k) SpecialCleared Jan 9, 200869-day reviewClass II21 CFR 870.1330

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Brivant, Ltd. · DQX Wire, Guide, Catheter

Cleared on Jan 9, 2008 after a 69-day review. The FDA summary names its predicate without a number. 5 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.

Decided
Jan 9, 2008
Review
69 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
0

28 later devices descend from it, 4 citing it directly. 5 of the 29 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2008: 1 descendant cleared2011: 2 descendants cleared2012: 6 descendants cleared2010: 1 descendant cleared2009: 1 descendant cleared2014: 3 descendants cleared2019: 2 descendants cleared, 1 with a Class I recall12020: 2 descendants cleared2015: 1 descendant cleared2024: 2 descendants cleared, 2 with a Class I recall22023: 3 descendants cleared, 1 with a Class I recall12025: 1 descendant cleared, 1 with a Class I recall12026: 3 descendants cleared20052010201520202025
  1. This deviceK073082 CPS Courier GuidewireBrivant, Ltd. · 2008
  2. Descendant · cites it directly · 13 of its ownK081187 Bridgepoint Medical Entera Percutaneous Coronary and Peripheral…Bridgepoint Medical · 2008
  3. Descendant · 2 generations on · 12 of its ownK083727 Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009
  4. Descendant · 2 generations on · 11 of its ownK102725 Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter…Bridge Medical, Inc. · 2011 · Recalled
  5. Descendant · cites it directly · 8 of its ownK120298 CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012
  6. Descendant · 2 generations on · 6 of its ownK190106 Intra-Operative Positioning System; Simple Curve Catheter, Reverse…Centerline Biomedical, Inc. · 2019 · Recalled (Class I)

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12011: 22012: 62014: 32015: 12019: 22020: 22023: 32024: 22025: 12026: 3
2008high 6 (2012) · low 0 (2013)2026

Class I recalls in this family

  • K190106 Intra-Operative Positioning System; Simple Curve…2 generations on · 2019
  • K242133 Intra-Operative Positioning System (IOPS®)…3 generations on · 2024
  • K241243 Intra-Operative Positioning System (IOPS®)…3 generations on · 2024
  • K230309 Intra-Operative Positioning System (IOPS®)…3 generations on · 2023

Most influential descendants

Showing 5 of 28 · See all
  • K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Bridgepoint Medical · 2008 · cites it directly13descendants
  • K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical · 2009 · 2 generations on12descendants
  • K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc. · 2011 · 2 generations on11descendants
  • K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi · 2012 · cites it directly8descendants
  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter…Centerline Biomedical, Inc. · 2019 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K073082CPS Courier GuidewireBrivant, Ltd.2008—
+1K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire…Bridgepoint Medical2008—
+2K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical2009—
+2K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model…Bridge Medical, Inc.20111
+1K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi2012—
+2K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve…Centerline Biomedical, Inc.2019Class I

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201120
201260
201430
201510
201921
202020
202331
202422
202511
202630
FIG. 1 — Lineage of K073082, 2008–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

5 devices in this family have a Class I recall. 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 DQX device

  1. #1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Brivant Guidewire
Named without a submission number
—

What descends from it? (28)

See all 28

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Bridgepoint Medical200813
K120298CPS Excel Mediguide Enabled GuidewireSt. Jude Medical, Cardiac Rhythm Management Divisi20128
K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd.20112
K102211Cruiser 18 GuidewireBrivant, Ltd.20101

Has anything in its family been recalled? (5 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 2 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
  • K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
  • K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K081187 (Bridgepoint Medical, 2008) has gone furthest, with 13 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The CPS Courier Guidewires are intended for use in the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

More from Brivant, Ltd.

7 FDA decisions under this applicant name. See the company

  • K122856Charter GuidewireBrivant, Ltd. · 2012
  • K120137Victory Guidewire (32 Models)Brivant, Ltd. · 2012
  • K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd. · 2011
  • K102211Cruiser 18 GuidewireBrivant, Ltd. · 2010
  • K0935153 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2 Piece Parodi Guidewire…Brivant, Ltd. · 2010

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K073082 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073082: CPS Courier Guidewire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073082

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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