510(k) · Cleared
ClearedInnerchange Micro-Introducer Catheter, Models 7900 Through 7905
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 5, 2007 as substantially equivalent to K000659 (Merit Medical Systems, Inc., 2000) and 2 other predicates after a 122-day review. Its family tree reaches back 3 generations to 1981. 2 of the 12 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jan 5, 2007
- Review
- 122 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K810412 (1981). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK810412 Usci Cardiovascular CatheterC.R. Bard, Inc. · 1981
- 2 generations backK041909 Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP)Vascular Solutions, Inc. · 2004
- 1 generation backK061565 Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Recalled (Class I)
- This deviceK062627 Innerchange Micro-Introducer Catheter, Models 7900 Through 7905Vascular Solutions, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK073585 Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902…Vascular Solutions, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK081846 Grebset Micro-Introducer Kit, Models 7950, 7951Vascular Solutions, Inc. · 2009 · Recalled
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810412 | Usci Cardiovascular Catheter | C.R. Bard, Inc. | 1981 | — |
| −2 | K041909 | Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) | Vascular Solutions, Inc. | 2004 | — |
| −1 | K061565 | Langston Dual Lumen Catheter | Vascular Solutions, Inc. | 2006 | Class I |
| 0 (this device) | K062627 | Innerchange Micro-Introducer Catheter, Models 7900 Through 7905 | Vascular Solutions, Inc. | 2007 | — |
| +1 | K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and… | Vascular Solutions, Inc. | 2008 | — |
| +2 | K081846 | Grebset Micro-Introducer Kit, Models 7950, 7951 | Vascular Solutions, Inc. | 2009 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
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.
2 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 DQO device
- #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000659 | Modification to Softouch Diagnostic Intravascular CatSummary page 1…Product Code: DQO Regulation: Class II, 21 CFR 870.1200 Predicate Device(s) * Merit Medical Angiographic Catheter (K000659) * Gait Micro-Introducer Kits (K000737) * Vascular Solutions Langston Dual Lumen Pressure Monitoring Catheter… | 2000 |
| * | K000737 | Coaxial Dilator SetSummary page 1…Regulation: Class II, 21 CFR 870.1200 Predicate Device(s) * Merit Medical Angiographic Catheter (K000659) * Gait Micro-Introducer Kits (K000737) * Vascular Solutions Langston Dual Lumen Pressure Monitoring Catheter (K061565) Device Description The I… | 2000 |
| * | K061565 | Langston Dual Lumen CatheterSummary page 1…ical Angiographic Catheter (K000659) * Gait Micro-Introducer Kits (K000737) * Vascular Solutions Langston Dual Lumen Pressure Monitoring Catheter (K061565) Device Description The InnerChange Micro-Introducer Catheter combines the function of a micro introducer and angi… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073585 | Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905 | 2008 | 1 |
Has anything in its family been recalled? (2 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.
- K061565Langston Dual Lumen CatheterVascular Solutions, Inc. · 2006 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K051395Langston Dual Lumen Pressure Monitoring CatheterVascular Solutions, Inc. · 2005 · 2 generations back · ◆ in the 2005 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K073585 (Vascular Solutions, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K000659.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DQO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQO
148in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQO
1in 2023
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · DQO
656in 2025
MAUDE reports naming product code DQO, 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 | 8 | 106 | 14 | 564 |
| 2008 | 3 | 80 | 4 | 726 |
| 2009 | 8 | 58 | 7 | 933 |
| 2010 | 7 | 137 | 11 | 556 |
| 2011 | 6 | 74 | 7 | 625 |
| 2012 | 15 | 94 | 2 | 532 |
| 2013 | 2 | — | 1 | 753 |
| 2014 | 3 | 109 | 0 | 601 |
| 2015 | 10 | 209 | 1 (1) | 628 |
| 2016 | 4 | 89 | 2 (1) | 614 |
| 2017 | 10 | 176 | 1 | 873 |
| 2018 | 10 | 234 | 2 | 777 |
| 2019 | 6 | 113 | 71 | 386 |
| 2020 | 3 | 30 | 4 (4) | 312 |
| 2021 | 1 | — | 0 | 338 |
| 2022 | 4 | 181 | 1 | 379 |
| 2023 | 4 | 73 | 1 (1) | 391 |
| 2024 | 4 | 148 | 0 | 511 |
| 2025 | 2 | — | 0 | 656 |
| 2026 | 3 | 85 | 24 (4) | — |
What is it indicated for?
The InnerChange TM micro-introducer catheter is intended for use in accessing the vascular system through a small gauge needle stick and for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062627: Innerchange Micro-Introducer Catheter, Models 7900 Through 7905.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062627
Report an extraction error
Are you the manufacturer?
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