510(k) Report

510(k) · Cleared

Cleared

Tandemheart Transseptal Cannula- EF 72

K082425510(k) SpecialCleared Sep 18, 200827-day reviewClass II21 CFR 870.4210

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

Cardiacassist, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Sep 18, 2008 as substantially equivalent to K052570 (Cardiacassist, Inc., 2006) and 2 other predicates after a 27-day review. Its family tree reaches back 3 generations to 1986.

Decided
Sep 18, 2008
Review
27 days
Class
Class II
Product code
DWF
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K854511 (1986). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1987: 1 other ancestor1993: 1 other ancestorK854511 · Elecath Percutaneous Left Atrial Cannulation Set · Electro-Catheter Corp. · 1986K030398 · Cardiacassist Transseptal Cannula Set, Model 5132-6221 · Cardiacassist, Inc. · 2003K052570 · Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 · Cardiacassist, Inc. · 2006 · recalled198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K052570 · Tandemheart Transseptal Cannula Set-EF, Model 5140-6221 · Cardiacassist, Inc. · 2006 · recalledK030398 · Cardiacassist Transseptal Cannula Set, Model 5132-6221 · Cardiacassist, Inc. · 2003K854511 · Elecath Percutaneous Left Atrial Cannulation Set · Electro-Catheter Corp. · 19860
  1. Root · 3 generations backK854511 Elecath Percutaneous Left Atrial Cannulation SetElectro-Catheter Corp. · 1986
  2. 2 generations backK030398 Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 2003
  3. 1 generation backK052570 Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006 · Recalled
  4. This deviceK082425 Tandemheart Transseptal Cannula- EF 72Cardiacassist, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K854511Elecath Percutaneous Left Atrial Cannulation SetElectro-Catheter Corp.1986—
−2K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc.2003—
−1K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc.20061
0 (this device)K082425Tandemheart Transseptal Cannula- EF 72Cardiacassist, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199310
FIG. 1 — Lineage of K082425, 1986–2008Source: 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.

Planning a device in DWF? 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 DWF device

  1. #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.7 · 8 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? (3)

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
*K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221
Summary page 1
…Classification Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Predicate Devices CardiacAssist TandemHeart Transseptal Cannula Set-EF (K052570) CardiacAssist Transseptal Cannula Set (K030398) Medtronic BioMedicus Pediatric Femoral Venous Cannula (K872033) D…
Cardiacassist, Inc.20061
*K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221
Summary page 1
…cular catheter, cannula, or tubing Predicate Devices CardiacAssist TandemHeart Transseptal Cannula Set-EF (K052570) CardiacAssist Transseptal Cannula Set (K030398) Medtronic BioMedicus Pediatric Femoral Venous Cannula (K872033) Device Description The TandemHeart Transseptal Ca…
Cardiacassist, Inc.2003—
*K872033Bio-Medicus Cannula-Tubing
Summary page 1
…ist TandemHeart Transseptal Cannula Set-EF (K052570) CardiacAssist Transseptal Cannula Set (K030398) Medtronic BioMedicus Pediatric Femoral Venous Cannula (K872033) Device Description The TandemHeart Transseptal Cannula Set-EF 72 consists of three main components, a 21 Fr Trans…
Bio Medicus, Inc.1987—

Also cleared against K052570: 1 other device →

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 22 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 1 other device also cites its predicate K052570.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DWF

4in 2025

2007: 22008: 62009: 82010: 32011: 52012: 102013: 92014: 142015: 92016: 32017: 52018: 52019: 32020: 32021: 52022: 22023: 22024: 32025: 42026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2008: 95 days median2009: 148 days median2010: 62 days median2011: 85 days median2012: 110 days median2013: 110 days median2014: 110 days median2015: 46 days median2016: 32 days median2017: 127 days median2018: 30 days median2019: 120 days median2020: 30 days median2021: 358 days median2024: 29 days median2025: 89 days median2026 (partial year): 81 days median
2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

2007: 252008: 252009: 212010: 262011: 132012: 372013: 14, 1 Class I2014: 62015: 3, 1 Class I2016: 32017: 2, 1 Class I2018: 102019: 22021: 32024: 42026 (partial year): 20
2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007: 1212008: 1262009: 992010: 1972011: 2122012: 2332013: 2382014: 3252015: 2182016: 1442017: 1012018: 1182019: 1792020: 1422021: 1622022: 2762023: 4702024: 4012025: 1,020
2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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
20072—25121
200869525126
200981482199
201036226197
201158513212
20121011037233
2013911014 (1)238
2014141106325
20159463 (1)218
20163323144
201751272 (1)101
201853010118
201931202179
20203300142
202153583162
20222—0276
20232—0470
20243294401
202548901,020
202688120—

What is it indicated for?

The TandemHeart Transseptal Cannula Set-EF 72 is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.

Indications for use as stated in the FDA summary.

Also cleared against K052570

1 other device cites the same predicate.

  • K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008

More from Cardiacassist, Inc.

21 FDA decisions under this applicant name. See the company

  • K233736LifeSPARC SystemCardiacassist, Inc. · 2024
  • K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc. · 2023
  • K232132LifeSPARC SystemCardiacassist, Inc. · 2023
  • K211830LifeSPARC SystemCardiacassist, Inc. · 2022
  • K202751TandemHeart Pump and Escort ControllerCardiacassist, Inc. · 2021

Recent decisions in DWF

The DWF category page

  • K263092Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 20262 recalls
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026
  • K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026

https://510kreport.com/device/K082425 · printed Nov 3, 2026

Cite this page

510(k) Report. “K082425: Tandemheart Transseptal Cannula- EF 72.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K082425

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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