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FDA 510(k)

TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA

K-Number: K844752 · 1985-01-02

ApplicantMansfield Scientific, Inc.
Decision Date1985-01-02
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA is the device name listed in this FDA 510(k) record. The listed applicant is Mansfield Scientific, Inc.. It received FDA 510(k) clearance on 1985-01-02 under 510(k) number K844752. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA?

TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA is a medical device that received FDA 510(k) clearance on 1985-01-02. The listed applicant is Mansfield Scientific, Inc.. The 510(k) number is K844752.

When did TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA receive FDA 510(k) clearance?

TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA received FDA 510(k) clearance on 1985-01-02, under 510(k) number K844752.

Who is the listed applicant for TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA?

The FDA 510(k) record lists Mansfield Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA?

The FDA product code for TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PA is DTB.

Related Clinical Trials

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Other records listing Mansfield Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K865017ANGIOSCOPEK870186ENDOMYOCARDIAL BIOPSY DEVICEK855103CIRIBART GYUDUBG CATGETERK853850EXPLORERK852797HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODEK851848PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER

View all 8 devices →

Related Devices (Code: DTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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