510(k) Report

PMA · Approved

Approved

Palmaz-Schatz (TM) Balloon Expandable Stent

P900043PMAApproved Aug 2, 19941,503-day reviewClass III

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

Cordis Corp. · MAF Stent, Coronary

Approved on Aug 2, 1994 through premarket approval, which rests on the device’s own clinical evidence after a 1,503-day review. 1 later device descends from it.

Decided
Aug 2, 1994
Review
1,503 days
Class
Class III
Product code
MAF
Recalls
None

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1990200020102020
  1. This deviceP900043 Palmaz-Schatz (TM) Balloon Expandable StentCordis Corp. · 1994
  2. Descendant · cites it directly · 0 of its ownK063431 15.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter…Spire Biomedical, Inc. · 2007 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28…Spire Biomedical, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P900043Palmaz-Schatz (TM) Balloon Expandable StentCordis Corp.1994—
+1K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24…Spire Biomedical, Inc.200748

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of P900043, 1994–2007Source: 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 PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MAF? 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
Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28…Spire Biomedical, Inc.20070

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?

  • Of its descendants, K063431 (Spire Biomedical, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MAF devices

MAF Stent, Coronary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAF

2in 2025

2007: 342008: 412009: 362010: 552011: 672012: 772013: 412014: 532015: 222016: 262017: 352018: 322019: 252020: 212021: 132022: 82023: 82024: 32025: 22026 (partial year): 4
2007high 77 (2012) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAF

Too few MAF 510(k)s in any year since 2007 to give a median.

Recalls per year · MAF

1in 2019

2007: 12008: 12009: 52019: 1
2007high 5 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAF

111in 2025

2007: 1,2012008: 1,2882009: 1,3702010: 1,5682011: 1,2332012: 1,0532013: 1,0492014: 8762015: 6642016: 6962017: 6952018: 6752019: 5612020: 4302021: 3292022: 2802023: 2072024: 2192025: 111
2007high 1,568 (2010) · low 111 (2025)2025

MAUDE reports naming product code MAF, 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
200734—11,201
200841—11,288
200936—51,370
201055—01,568
201167—01,233
201277—01,053
201341—01,049
201453—0876
201522—0664
201626—0696
201735—0695
201832—0675
201925—1561
202021—0430
202113—0329
20228—0280
20238—0207
20243—0219
20252—0111
20264—0—

More from Cordis Corp.

551 FDA decisions under this applicant name. See the company

  • P020026/S086Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2014
  • K130981Flexstent Biliary Self Expanding Stent System; S.M.a.R.T. RE-Flex Biliary Elf-Expanding Stent SystemCordis Corp. · 2014
  • K112797Powerflex Pro Percutaneous Transluminal Angioplasty CatheterCordis Corp. · 2012
  • P020026/S082Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012
  • P020026/S085Cypher Sirolimus-Eluting Coronary StentCordis Corp. · 2012

Recent decisions in MAF

The MAF category page

  • P160003/S024PRO-Kinetic Energy Coronary Stent SystemBiotronik AG · 2026
  • P160003/S022PRO-Kinetic Energy Coronary Stent SystemBiotronik AG · 2026
  • P160003/S026PRO-Kinetic Energy Coronary Stent SystemBiotronik AG · 2026
  • P130030Rebel Platinum Chromium Coronary Stent System Monorail and Over the WireBoston Scientific Corp · 20261 recall
  • P160003/S025PRO-Kinetic Energy Coronary Stent SystemBiotronik AG · 2025

https://510kreport.com/device/P900043 · printed Nov 6, 2026

Cite this page

510(k) Report. “P900043: Palmaz-Schatz (TM) Balloon Expandable Stent.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P900043

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026