510(k) Report

510(k) · Cleared

Cleared

Premere Delivery Sheath, Model PDS

K043084510(k) TraditionalCleared May 2, 2005175-day reviewClass II21 CFR 870.1340

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

Velocimed, Inc. · DYB Introducer, Catheter

Cleared on May 2, 2005 as substantially equivalent to K012489 (Appriva Medical, Inc., 2001) and 2 other predicates after a 175-day review. Its family tree reaches back 2 generations to 2001. 9 later devices descend from it.

Decided
May 2, 2005
Review
175 days
Class
Class II
Product code
DYB
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K002054 (2001). 4 ancestors in all, the oldest K964518 (1997). 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor2009: 2 descendants cleared2011: 1 descendant cleared2016: 1 descendant cleared2010: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2013: 1 descendant clearedK002054 · X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 · Appriva Medical, Inc. · 2001K012489 · Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10 · Appriva Medical, Inc. · 20011995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 5 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K012489 · Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10 · Appriva Medical, Inc. · 2001K002054 · X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1 · Appriva Medical, Inc. · 20010
  1. Root · 2 generations backK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
  2. 1 generation backK012489 Modification to: X-Sept Transseptal Shealth and Transition Catheter…Appriva Medical, Inc. · 2001
  3. This deviceK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
  4. Descendant · cites it directly · 8 of its ownK083793 Steerable Guide CatheterEvalve, Inc. · 2009
  5. Descendant · 2 generations on · 7 of its ownK091596 Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
  6. Descendant · 2 generations on · 6 of its ownK093866 Evalve Steerable Guide CatheterEvalve, Inc. · 2010
  7. Descendant · 2 generations on · 5 of its ownK100789 Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010
  8. Descendant · 3 generations on · 2 of its ownK120086 Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions…Cardiosolutions · 2012

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 22010: 22011: 12012: 12013: 12014: 12016: 1
2009high 2 (2009) · low 0 (2015)2026

Most influential descendants

Showing 5 of 9 · See all
  • K083793Steerable Guide CatheterEvalve, Inc. · 2009 · cites it directly8descendants
  • K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009 · 2 generations on7descendants
  • K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010 · 2 generations on6descendants
  • K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010 · 2 generations on5descendants
  • K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro Steerable…Cardiosolutions · 2012 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002054X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90…Appriva Medical, Inc.2001—
−1K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with…Appriva Medical, Inc.2001—
0 (this device)K043084Premere Delivery Sheath, Model PDSVelocimed, Inc.2005—
+1K083793Steerable Guide CatheterEvalve, Inc.2009—
+2K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc.2009—
+2K093866Evalve Steerable Guide CatheterEvalve, Inc.2010—
+2K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc.2010—
+3K120086Cariosolutions Percu-Pro Steerable Introdcer 65CM Cariosolutions Percu-Pro…Cardiosolutions2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201020
201110
201210
201310
201410
201610
FIG. 1 — Lineage of K043084, 2001–2016Source: 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 DYB? 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 DYB device

  1. #1 K251051 AuST Steerable Sheathscore 18.0 · 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? (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
*K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator)…
Summary page 2
…The PremereTM Delivery Sheath covered by this submission is substantially another legally marketed Catheter Introducer: * X-Sept Transseptal Sheath (K012489, Appriva Medical, Inc) * Transseptal Super Arrow-Flex Percutaneous Sheath Introducer Set (K970229, Arrow…
Appriva Medical, Inc.2001—
*K970229Arrow Transseptal Super Arrow-Flex Percutaneous Set
Summary page 2
…d Catheter Introducer: * X-Sept Transseptal Sheath (K012489, Appriva Medical, Inc) * Transseptal Super Arrow-Flex Percutaneous Sheath Introducer Set (K970229, Arrow International Inc) and, * Fast-Cath Transseptal Catheter Introducer (K964518, Daig Corp.).…
Arrow Intl., Inc.1998—
*K964518Fast-Cath Transseptal Catheter Introducer
Summary page 2
…nsseptal Super Arrow-Flex Percutaneous Sheath Introducer Set (K970229, Arrow International Inc) and, * Fast-Cath Transseptal Catheter Introducer (K964518, Daig Corp.). principles The Premer…
Daig Corp.19974

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083793Steerable Guide CatheterEvalve, Inc.20098

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 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K083793 (Evalve, Inc., 2009) has gone furthest, with 8 descendants of its own.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYB

16in 2025

2007: 122008: 172009: 142010: 182011: 172012: 222013: 262014: 302015: 172016: 192017: 242018: 192019: 182020: 92021: 122022: 132023: 152024: 182025: 162026 (partial year): 17
2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007: 95 days median2008: 37 days median2009: 52 days median2010: 123 days median2011: 100 days median2012: 128 days median2013: 118 days median2014: 122 days median2015: 129 days median2016: 95 days median2017: 70 days median2018: 156 days median2019: 47 days median2020: 49 days median2021: 78 days median2022: 143 days median2023: 55 days median2024: 56 days median2025: 63 days median2026 (partial year): 59 days median
2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007: 152008: 92009: 252010: 182011: 42012: 32013: 5, 1 Class I2014: 22015: 2, 1 Class I2016: 45, 3 Class I2017: 22, 1 Class I2018: 12019: 22020: 21, 21 Class I2021: 62022: 22023: 102024: 22025: 32026 (partial year): 23, 21 Class I
2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007: 3162008: 4232009: 3992010: 4452011: 6282012: 8982013: 7432014: 7802015: 9132016: 1,2342017: 1,6722018: 1,9032019: 2,4502020: 2,4652021: 2,8352022: 4,0842023: 3,7752024: 3,9312025: 4,539
2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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
2007129515316
200817379423
2009145225399
20101812318445
2011171004628
2012221283898
2013261185 (1)743
2014301222780
2015171292 (1)913
2016199545 (3)1,234
2017247022 (1)1,672
20181915611,903
2019184722,450
202094921 (21)2,465
2021127862,835
20221314324,084
20231555103,775
2024185623,931
2025166334,539
2026175923 (21)—

What is it indicated for?

The Premere TM Delivery Sheath is indicated for use in intravascular introduction of therapeutic devices into the left atrium of the heart through the septal wall.

Indications for use as stated in the FDA summary.

More from Velocimed, Inc.

5 FDA decisions under this applicant name. See the company

  • K052523Proxis SystemVelocimed, Inc. · 2006
  • K042117Proxis System, Model Eps 101Velocimed, Inc. · 2005
  • K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 20041 Class I recall
  • K040922Venture Wire Control CatheterVelocimed, Inc. · 20041 Class I recall

Recent decisions in DYB

The DYB category page

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https://510kreport.com/device/K043084 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043084: Premere Delivery Sheath, Model PDS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043084

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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