510(k) · Cleared
ClearedBiocardia Universal Deflectable Guide Catheter, Model 000664
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocardia, Inc. · DQO Catheter, Intravascular, Diagnostic
Cleared on Jan 24, 2002 as substantially equivalent to K961280 (Scimed Life Systems, Inc., 1996) and 2 other predicates after a 161-day review. Its family tree reaches back 2 generations to 1994. 3 of the 43 devices in its family, counting itself, have a Class I recall. 37 later devices descend from it.
- Decided
- Jan 24, 2002
- Review
- 161 days
- Class
- Class II
- Product code
- DQO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931794 (1994). 5 ancestors in all. 37 later devices descend from it, 3 citing it directly. 3 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK931794 Marinr Series EP Diagnostic CathetersMedtronic Cardiorhythm · 1994
- 1 generation backK974683 Naviport Deflectable Tip Guiding CatheterCardima, Inc. · 1999
- This deviceK012749 Biocardia Universal Deflectable Guide Catheter, Model 000664Biocardia, Inc. · 2002
- Descendant · cites it directly · 31 of its ownK040922 Venture Wire Control CatheterVelocimed, Inc. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 30 of its ownK042910 Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 28 of its ownK061843 Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · Recalled (Class I)
- Descendant · 4 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled
- Descendant · 5 generations on · 14 of its ownK101591 Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · Recalled
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 37 · See all- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · cites it directly31descendants
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 2 generations on30descendants
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 3 generations on28descendants
- K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 4 generations on24descendants
- K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 2010 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931794 | Marinr Series EP Diagnostic Catheters | Medtronic Cardiorhythm | 1994 | — |
| −1 | K974683 | Naviport Deflectable Tip Guiding Catheter | Cardima, Inc. | 1999 | — |
| 0 (this device) | K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664 | Biocardia, Inc. | 2002 | — |
| +1 | K040922 | Venture Wire Control Catheter | Velocimed, Inc. | 2004 | Class I |
| +2 | K042910 | Venture Wire Control Catheter, Model WCC | Velocimed, Inc. | 2004 | Class I |
| +3 | K061843 | Venture Wire Control Catheter, Model WCC | St Jude Medical | 2006 | Class I |
| +4 | K080987 | Bridgepoint Medical Stingray Device and Accessories | Bridgepoint Medical | 2009 | 1 |
| +5 | K101591 | Stingray Orienting Balloon Catheter | Bridgepoint Medical | 2010 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 2 |
| 2005 | 1 | 0 |
| 2006 | 1 | 1 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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.
3 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 |
|---|---|---|---|
| * | K961280 | Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10FSummary page 1…r (21 CFR 870.1250) Equivalent Device: The subject device is substantially equivalent in intended use and/or method of operation to the SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683). Intended Use… | 1996 |
| * | K971034 | Usci Mainstay Guiding CatheterSummary page 1…bject device is substantially equivalent in intended use and/or method of operation to the SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683). Intended Use: . The BioCardia Universal Guide Catheter is… | 1997 |
| * | K974683 | Naviport Deflectable Tip Guiding CatheterSummary page 1…od of operation to the SCIMED Triguide Guide Catheter (K961280), the USCI Mainstay Guiding Catheter (K971034) and the Cardima Naviport Deflectable Tip Guiding Catheter (K974683). Intended Use: . The BioCardia Universal Guide Catheter is intended to serve as a conduit for access into the chambers of the… | 1999 |
What descends from it? (37)
See all 373 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K040922Venture Wire Control CatheterVelocimed, Inc. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K042910Venture Wire Control Catheter, Model WCCVelocimed, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K061843Venture Wire Control Catheter, Model WCCSt Jude Medical · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K040922 (Velocimed, Inc., 2004) has gone furthest, with 31 descendants of its own.
- 1 other device also cites its predicate K961280.
How does its category compare?
All DQO devicesDQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 BioCardia Universal Deflectable Guide Catheter is intended to serve as a conduit for access in the chambers and coronary vasculature of the heart
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012749 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012749
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026